FDA Dental device clearances: 480 since Nov 2024

Name: FDA dental device clearances and approvals
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

The full list. FDA dental device clearances and approvals: 480 rows for $24, FDA 510(k) and PMA decisions dated November 11, 2024 to October 30, 2026. The list gains about 20 rows a month. The new rows come each week by email, $19 a month.

Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (pathway, device name, applicant address, contact, date received, device type and 6 more), which open on your screen as soon as the payment clears and come by email. The weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-clearances/panel/dental, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: openFDA device 510(k) and PMA (U.S. Food and Drug Administration).

FDA made 480 device decisions in dental (FDA review panel) from November 11, 2024 to October 30, 2026: 461 510(k) clearances and De Novo grants and 19 PMA approvals and supplements, for 296 applicants. The newest, K263860 on October 30, 2026, is Shining3D Clear Aligner System from Hangzhou SHINING3D Dental Technology Co., Ltd..

The request: Every new FDA clearance or approval of a dental device, with the applicant, its address and the product code. $10 of credit on sign-up, no card.

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SpecStream is the live web data engine for teams and agents. It reads every new FDA device clearance and approval as openFDA publishes it, and this page is that reading. Ask for the specialties, product codes or states you follow and each new decision arrives in your sheet, CRM, Slack or agent with the applicant and its address.

480Decisions
461510(k) and De Novo
19PMA
October 30, 2026Latest decision

Newest decisions

The newest 100 of 480, each linked to its FDA record. The full list adds the applicant's address, the 510(k) contact as FDA prints it, the device class and the date received.

Decision date	Number	Device	Applicant	Location	Decision	Type	Product code	Source
October 30, 2026	K263860	Shining3D Clear Aligner System	Hangzhou SHINING3D Dental Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	NXC	accessdata.fda.gov
October 30, 2026	K262685	Zirconia Collective 4Y Dental Zirconia Blank	Zirconia Collective, Inc.	Colorado	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
October 29, 2026	K262756	Zirconia Dental Ceramics and Staining Solution	Fanen New Materials Technology (Suzhou) Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
October 29, 2026	K262415	OSSIX Plus	Datum Dental, Ltd.	Israel	Substantially Equivalent	510(k) traditional	NPL	accessdata.fda.gov
October 29, 2026	K260356	EndoColibri	Koehrer Medical Engineering GmbH	Germany	Substantially Equivalent	510(k) traditional	NYL	accessdata.fda.gov
October 27, 2026	K262775	AquaVance Clear Fluoride Treatment	The Belport Company Inc., DBA Gingi-Pak	California	Substantially Equivalent	510(k) traditional	LBH	accessdata.fda.gov
October 23, 2026	K260421	LuxDesign	LuxCreo, Inc.	Illinois	Substantially Equivalent	510(k) traditional	PNN	accessdata.fda.gov
October 23, 2026	K260275	Mobile Dental Solution (Model: DS50, DS70, DS90)	Guangdong JINME Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EIA	accessdata.fda.gov
October 22, 2026	K261295	MultiNeO Dental Implant System	Alpha Bio Tec , Ltd.	Israel	Substantially Equivalent	510(k) traditional	DZE	accessdata.fda.gov
October 21, 2026	K262980	INNI-CERA (BCM-W500, BCM-W1000)	DentMedi Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
October 20, 2026	K262937	PDR Airway Device	Park Dental Research Corp.	Oklahoma	Substantially Equivalent	510(k) traditional	LRK	accessdata.fda.gov
October 20, 2026	K262421	Daybreak Impression Material	Sleepcare, LLC	California	Substantially Equivalent	510(k) traditional	SHI	accessdata.fda.gov
October 16, 2026	K262523	Amber Arte	Hass Corp.	South Korea	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
October 16, 2026	K262478	BCS Bioceramic Sealer	BCS Device Pte., Ltd.	Singapore	Substantially Equivalent	510(k) traditional	KIF	accessdata.fda.gov
October 13, 2026	K262433	OrthoFit Aligner (OrthoFit Aligner A2)	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	DYH	accessdata.fda.gov
October 13, 2026	K261321	Yomi S Robotic System	Neocis, Inc.	Florida	Substantially Equivalent	510(k) traditional	QRY	accessdata.fda.gov
October 9, 2026	K260913	CMF Titanium Splints	Materialise NV	Belgium	Substantially Equivalent	510(k) traditional	DZJ	accessdata.fda.gov
October 9, 2026	K260096	Wishbone HAE	Wishbone SA	Belgium	Substantially Equivalent	510(k) traditional	NPM	accessdata.fda.gov
October 8, 2026	K263680	One Coat Bond; One Coat Bond SL	Dent4You AG	Switzerland	Substantially Equivalent	510(k) traditional	KLE	accessdata.fda.gov
October 7, 2026	K262378	Dr.AlignNavi	InnoDtech, Inc.	South Korea	Substantially Equivalent	510(k) traditional	PNN	accessdata.fda.gov
October 6, 2026	K260136	Forza	True Function Laboratory, Inc.	California	Substantially Equivalent	510(k) abbreviated	LRK	accessdata.fda.gov
October 1, 2026	K260029	Firstar Dental Handpieces	FDC Technology Industry Co.	Washington	Substantially Equivalent	510(k) traditional	EFB	accessdata.fda.gov
October 1, 2026	K260027	Firstar Dental Electric Motor	FDC Technology Industry Co.	Washington	Substantially Equivalent	510(k) traditional	EBW	accessdata.fda.gov
September 30, 2026	K261663	EzSensor HD	Qpix Solutions, Inc.	North Carolina	Substantially Equivalent	510(k) traditional	MUH	accessdata.fda.gov
September 30, 2026	K261327	Elos Accurate Hybrid Base	Elos Medtech Pinol A/S	Denmark	Substantially Equivalent	510(k) traditional	NHA	accessdata.fda.gov
September 25, 2026	K262983	EsTemp Implant	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	EMA	accessdata.fda.gov
September 25, 2026	K262196	Invisalign System	Align Technology, Inc.	California	Substantially Equivalent	510(k) traditional	PNN	accessdata.fda.gov
September 25, 2026	K254210	REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)	Hyundai Bioland Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	NPM	accessdata.fda.gov
September 24, 2026	K262252	MPa Max adhesive	Den-Mat Holdings, LLC	California	Substantially Equivalent	510(k) traditional	KLE	accessdata.fda.gov
September 23, 2026	K262207	Cemented Plus Abutment	Unidental Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	NHA	accessdata.fda.gov
September 23, 2026	K262144	DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece	SETAGAYA SEIKI Co., Ltd.	Japan	Substantially Equivalent	510(k) traditional	EFB	accessdata.fda.gov
September 21, 2026	K262982	Core·it Dual	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	EBF	accessdata.fda.gov
September 21, 2026	K260940	BellaTek Bars	ZimVie US Corp, LLC	Florida	Substantially Equivalent	510(k) special	NHA	accessdata.fda.gov
September 18, 2026	P840062/S099	CollaCote, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery	Integra Lifesciences Corp.	New Jersey	30-day notice accepted	PMA 30-day notice	LPG	accessdata.fda.gov
September 17, 2026	K261392	TriActive Dental Implant System	Paragon Implant Mfg., LLC	California	Substantially Equivalent	510(k) abbreviated	DZE	accessdata.fda.gov
September 16, 2026	K261888	ClearClub Impression Material	ClearClub	California	Substantially Equivalent	510(k) traditional	SHI	accessdata.fda.gov
September 16, 2026	K254152	Dia-X Sil Light Body	DiaDent Group International	South Korea	Substantially Equivalent	510(k) traditional	ELW	accessdata.fda.gov
September 16, 2026	K254142	Dia-X Sil Heavy Body	DiaDent Group International	South Korea	Substantially Equivalent	510(k) traditional	ELW	accessdata.fda.gov
September 14, 2026	K260795	Hand-held Dental X-ray System (HyperLight-M)	Changzhou Sifary Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EHD	accessdata.fda.gov
September 11, 2026	K262050	Vioseal X	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	KIF	accessdata.fda.gov
September 10, 2026	K262202	Cerasmart Forte	GC America, Inc.	Illinois	Substantially Equivalent	510(k) traditional	EBF	accessdata.fda.gov
September 10, 2026	K254009	Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)	Lakong Medical Devices Co., Ltd.	China	Substantially Equivalent	510(k) traditional	SJH	accessdata.fda.gov
September 8, 2026	K261987	Reusable SmartPeg	Osstell AB	Sweden	Substantially Equivalent	510(k) traditional	EKX	accessdata.fda.gov
September 4, 2026	K253909	NeoPEX Pre-Mixed Obturation Paste	NuSmile, Ltd.	Texas	Substantially Equivalent	510(k) traditional	KIF	accessdata.fda.gov
September 3, 2026	K262243	Profisil Free	Kettenbach GmbH & Co. KG	Germany	Substantially Equivalent	510(k) traditional	LBH	accessdata.fda.gov
August 31, 2026	K261695	Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)	Guilin Kevin Peter Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EBF	accessdata.fda.gov
August 28, 2026	K253954	X-Guide Surgical Navigation System	X-Nav Technologies, LLC	Pennsylvania	Substantially Equivalent	510(k) traditional	QRY	accessdata.fda.gov
August 27, 2026	K262104	Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)	Ram.Shaw Pte., Ltd.	Singapore	Substantially Equivalent	510(k) special	LRK	accessdata.fda.gov
August 27, 2026	K261802	Glidewell Denture Base Resin	Prismatik Dentalcraft, Inc.	California	Substantially Equivalent	510(k) traditional	EBI	accessdata.fda.gov
August 26, 2026	P050053/S066	INFUSE BONE GRAFT	Medtronic, Inc.	Tennessee	Approved	PMA 180-day supplement	NPZ	accessdata.fda.gov
August 25, 2026	K261514	Calcium Hydroxide Temporary Filling Material (KP-Cal)	Guilin Kevin Peter Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	KIF	accessdata.fda.gov
August 25, 2026	K254304	iNOS intraoral biosensor	Achaemenid, LLC	Massachusetts	Substantially Equivalent	510(k) traditional	PLC	accessdata.fda.gov
August 24, 2026	K254286	Guided Bone Regeneration System	DentalMaster(Xiamen)Medical Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	DZL	accessdata.fda.gov
August 21, 2026	K262074	Any-Zircos	Mediclus Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
August 19, 2026	K260463	ZEROS Dental Implant System	Zeros Co., Ltd.	South Korea	Substantially Equivalent	510(k) special	DZE	accessdata.fda.gov
August 17, 2026	K260137	KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual...	KLS-Martin L.P.	Florida	Substantially Equivalent	510(k) traditional	JEY	accessdata.fda.gov
August 13, 2026	K261626	UltraPrint Flexible Denture UV	Guangzhou Heygears IMC., Inc.	China	Substantially Equivalent	510(k) traditional	EBI	accessdata.fda.gov
August 13, 2026	K254201	Any-Cem	Mediclus Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	EMA	accessdata.fda.gov
August 7, 2026	K261937	PacTemp Automix NE	The Belport Company Inc., DBA Gingi-Pak	California	Substantially Equivalent	510(k) traditional	EMA	accessdata.fda.gov
August 7, 2026	K251544	Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)	Lakong Medical Devices Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EIA	accessdata.fda.gov
August 6, 2026	K253999	Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment...	Nobel Biocare AB	Sweden	Substantially Equivalent	510(k) traditional	NHA	accessdata.fda.gov
August 5, 2026	K261456	Ruthinium Disc	Dental Manufacturing S.p.A.	Italy	Substantially Equivalent	510(k) traditional	POW	accessdata.fda.gov
August 3, 2026	P040013/S033	GEM21S® Growth Factor Enhanced Matrix Implementation of Restricted Access Barrier System (RABS) at Pyramid	Lynch Biologics, LLC	Tennessee	Approved	PMA 135-day supplement	NPZ	accessdata.fda.gov
July 31, 2026	K262681	NanoCeram Resin	3bfab Teknoloji A.S.	Turkey	Substantially Equivalent	510(k) traditional	EBI	accessdata.fda.gov
July 31, 2026	K261912	SnØreNegatØr	DnB Innovations, LLC	Texas	Substantially Equivalent	510(k) traditional	LRK	accessdata.fda.gov
July 31, 2026	K253655	Angled Screwdriver MED (M-SD090)	W&H Dentalwerk Bürmoos GmbH	Austria	Substantially Equivalent	510(k) traditional	DZI	accessdata.fda.gov
July 30, 2026	K262239	Obsidian® Press Over Zirconia	Prismatik Dentalcraft, Inc.	California	Substantially Equivalent	510(k) special	EIH	accessdata.fda.gov
July 28, 2026	P050053/S069	Infuse Bone Graft	Medtronic, Inc.	Tennessee	Approved	PMA 180-day supplement	NPZ	accessdata.fda.gov
July 27, 2026	P020016/S010	Total Temporomandibular Joint Replacement System	Biomet Microfixation, Inc.	Florida	Approved	PMA 180-day supplement		accessdata.fda.gov
July 25, 2026	K253206	METICULY Patient-specific CMF solution	Meticuly Co., Ltd.	Thailand	Substantially Equivalent	510(k) traditional	JEY	accessdata.fda.gov
July 21, 2026	K261728	One-Fil LC	Mediclus Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	EJK	accessdata.fda.gov
July 17, 2026	K261046	Dental Zirconia Blank & Coloring Liquid	Hunan Qinghao Puzhong Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
July 9, 2026	K261166	DIA-CEM	DiaDent Group International	South Korea	Substantially Equivalent	510(k) traditional	EMA	accessdata.fda.gov
July 8, 2026	K262300	Denture Base Resin V2	Formlabs Ohio, Inc.	Ohio	Substantially Equivalent	510(k) abbreviated	EBI	accessdata.fda.gov
July 6, 2026	K253317	Cytrans Elashield	GC America, Inc.	Illinois	Substantially Equivalent	510(k) traditional	LYC	accessdata.fda.gov
July 2, 2026	K261847	iTero Lumina Pro	Align Technology , Ltd.	Israel	Substantially Equivalent	510(k) special	NTK	accessdata.fda.gov
July 2, 2026	K261129	OrthoFit	Spident Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	DYH	accessdata.fda.gov
July 2, 2026	K260527	FACE4D Aligner	Avinent Implant System S.L.U.	Spain	Substantially Equivalent	510(k) traditional	NXC	accessdata.fda.gov
July 1, 2026	K262228	Transcend Bulk Fill Flowable Composite	Ultradent Products, Inc.	Utah	Substantially Equivalent	510(k) traditional	EBF	accessdata.fda.gov
July 1, 2026	K261485	Tetric plus Fill;Tetric plus Flow	Ivoclar Vivadent, Inc.	New York	Substantially Equivalent	510(k) traditional	EBF	accessdata.fda.gov
July 1, 2026	K261474	DENTCA Tru Flexible	Dentca, Inc.	California	Substantially Equivalent	510(k) traditional	EBI	accessdata.fda.gov
July 1, 2026	K261147	Neodent Implant System - NeoConvert Fit	JJGC Indústria e Comércio de Materiais Dentários S.A.	Brazil	Substantially Equivalent	510(k) traditional	NHA	accessdata.fda.gov
June 30, 2026	K262195	Dandy Ceramic Stain and Glaze	Zima International Inc., dba Dandy	New York	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
June 29, 2026	K261415	Injectable Root Canal Sealer (KP-Root SP)	Guilin Kevin Peter Technology Co., Ltd.	China	Substantially Equivalent	510(k) traditional	KIF	accessdata.fda.gov
June 29, 2026	K260918	Zolid Lunaris	Amann Girrbach AG	Austria	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
June 27, 2026	K261122	MIST IC	Imagine Milling Technologies, LLC	Virginia	Substantially Equivalent	510(k) traditional	NHA	accessdata.fda.gov
June 26, 2026	K260061	BioHorizons CEREC Compatible Ti-Bases	BioHorizons Implant Systems, Inc.	Alabama	Substantially Equivalent	510(k) traditional	NHA	accessdata.fda.gov
June 25, 2026	K251188	UNIQA® Dental Implants System	Uniqa Dental, Ltd.	Israel	Substantially Equivalent	510(k) traditional	DZE	accessdata.fda.gov
June 18, 2026	K261246	SRGC-06	GC America, Inc.	Illinois	Substantially Equivalent	510(k) traditional	EBF	accessdata.fda.gov
June 18, 2026	K253776	Implantmed Plus II & Piezomed Plus II Module	W&H Dentalwerk Buermoos GmbH	Austria	Substantially Equivalent	510(k) traditional	DZI	accessdata.fda.gov
June 18, 2026	K253131	Curing Light (M-Cure 6)	Guangzhou Rebornendo Medical Instrument Co., Ltd.	China	Substantially Equivalent	510(k) traditional	EBZ	accessdata.fda.gov
June 18, 2026	K251232	MegaGen Zygoma Dental Implant System	Megagen Implant Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	DZE	accessdata.fda.gov
June 18, 2026	K250806	Dental Implant System	A.B. Dental Devices , Ltd.	Israel	Substantially Equivalent	510(k) traditional	DZE	accessdata.fda.gov
June 17, 2026	K260006	INOSS System	Inosys, Inc.	New York	Substantially Equivalent	510(k) traditional	DZE	accessdata.fda.gov
June 16, 2026	K253723	BOSS	Medpark Co., Ltd.	South Korea	Substantially Equivalent	510(k) traditional	NPM	accessdata.fda.gov
June 15, 2026	K253922	Neodent Scannable Healing Abutment	JJGC Indústria e Comércio de Materiais Dentários S.A.	Puerto Rico	Substantially Equivalent	510(k) traditional	NHA	accessdata.fda.gov
June 12, 2026	K261366	Virtus	Somnomed, Inc.	Texas	Substantially Equivalent	510(k) special	LRK	accessdata.fda.gov
June 11, 2026	K261251	Snorbliss® Anti-Snoring Device	Endeavor Commerce, LLC	Wyoming	Substantially Equivalent	510(k) traditional	LRK	accessdata.fda.gov
June 11, 2026	K260859	Rosetta SM, Rosetta SP	Hass Corp.	South Korea	Substantially Equivalent	510(k) traditional	EIH	accessdata.fda.gov
June 11, 2026	K254145	Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)	Smart Denture Conversions, LLC	North Carolina	Substantially Equivalent	510(k) abbreviated	NHA	accessdata.fda.gov

Applicants with the most decisions

Applicant	Decisions	Latest
Mediclus Co., Ltd.	12	August 21, 2026
Dentsply Sirona, Inc.	9	April 15, 2026
Institut Straumann AG	8	May 7, 2026
Spident Co., Ltd.	7	October 13, 2026
GC America, Inc.	7	September 10, 2026
Prismatik Dentalcraft, Inc.	7	August 27, 2026
Terrats Medical SL	7	June 9, 2026
Aidite (Qinhuangdao) Technology Co., Ltd.	7	April 6, 2026
Hangzhou SHINING3D Dental Technology Co., Ltd.	6	October 30, 2026
DiaDent Group International	6	September 16, 2026
Geistlich Pharma AG	6	November 25, 2025
Integra Lifesciences Corp.	5	September 18, 2026
Medtronic, Inc.	5	August 26, 2026
JJGC Indústria e Comércio de Materiais Dentários S.A.	5	July 1, 2026
Voco GmbH	5	May 1, 2026
Dentsply Sirona	5	December 9, 2025
Arum Dentistry Co., Ltd.	5	July 23, 2025
Elos Medtech Pinol A/S	4	September 30, 2026
Align Technology, Inc.	4	September 25, 2026
Paragon Implant Mfg., LLC	4	September 17, 2026

By decision type

Decision type	Decisions	Latest
510(k) traditional	401	October 30, 2026
510(k) special	37	September 25, 2026
510(k) abbreviated	22	October 6, 2026
PMA 30-day notice	11	September 18, 2026
PMA 180-day supplement	5	August 26, 2026
PMA 135-day supplement	2	August 3, 2026
De Novo	1	November 26, 2025
PMA special supplement	1	July 23, 2025

By state or country

State or country	Decisions	Latest
South Korea	73	October 21, 2026
China	72	October 30, 2026
California	54	October 27, 2026
Germany	24	October 29, 2026
Pennsylvania	22	August 28, 2026
Switzerland	21	October 8, 2026
Israel	17	October 29, 2026
Spain	17	July 2, 2026
Brazil	14	July 1, 2026
Illinois	12	October 23, 2026
New York	10	July 1, 2026
Florida	9	October 13, 2026
Japan	8	September 23, 2026
New Jersey	8	September 18, 2026
Texas	7	September 4, 2026
Tennessee	7	August 26, 2026
Denmark	6	September 30, 2026
Sweden	6	September 8, 2026
Italy	6	August 5, 2026
Singapore	5	October 16, 2026
Washington	5	October 1, 2026
Massachusetts	5	August 25, 2026
Austria	5	July 31, 2026
North Carolina	4	September 30, 2026
Taiwan	4	September 17, 2025

Where FDA publishes these decisions

CC0 1.0 (openFDA). Decisions are as FDA publishes them in its 510(k) and PMA databases, read through openFDA. A PMA row is the original approval or one supplement. The panel is the FDA advisory committee that reviewed the device. FDA adds decisions to openFDA some weeks after their date, so the newest weeks fill in later. The 510(k) contact is in the full list only, as FDA prints it for the submission. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.