Data / Medical devices / Brazil / JJGC Industria e Comercio de Materiais Dentarios SA

JJGC Industria e Comercio de Materiais Dentarios SA: FDA-registered device maker in Curitiba Parana, Brazil, 57 510(k) clearances

Name: JJGC Industria e Comercio de Materiais Dentarios SA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

JJGC Industria e Comercio de Materiais Dentarios SA is registered with the FDA (registration 3008261720) in Curitiba Parana, Brazil. It lists 21 device types. The FDA files 57 510(k) clearances under its listings, the newest dated July 1, 2026. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch JJGC Industria e Comercio de Materiais Dentarios SA

FDA registration number: 3008261720
Address: Avenida Juscelino Kubitschek de Olivera, 3291, Curitiba Parana, Brazil, 81270-200
Owner or operator: INSTITUT STRAUMANN AG (9005052)
Roles: Contract manufacturer, Manufacturer
First device listed: July 2, 1999
Registered through: 2027
Brand names listed: Chisel, Complement Kit Cases, Dental Implant Accesories, EUROPOST, EXCELPOST, Equator Attachment, Medentika Custom Abutments Gold Hue, NUVO CF Implant System and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Aligner, Sequential	NXC	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Attachment, Precision, All	EGG	1	Manufacturer	accessdata.fda.gov
Bone Mill	LYS	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Chisel, Bone, Surgical	EML	1	Manufacturer	accessdata.fda.gov
Chisel, Osteotome, Surgical	EMM	1	Manufacturer	accessdata.fda.gov
Curette, Surgical, Dental	EMK	1	Manufacturer	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Manufacturer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
Handle, Instrument, Dental	EJB	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Orthodontic	OAT	2	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Indirect Bonding Tray	QJJ	1	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 1, 2026	K261147	Neodent Implant System - NeoConvert Fit	NHA	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
June 15, 2026	K253922	Neodent Scannable Healing Abutment	NHA	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
May 7, 2026	K260460	Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
January 7, 2026	K252727	Neodent InLab Validated Workflow	NHA	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
December 12, 2025	K252090	Pterygoid Indication for GM Helix Implants	DZE	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
August 18, 2025	K250271	Neodent Implant System - Zirconia Implant System	DZE	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
May 27, 2025	K250614	Neodent Implant System - Custom Abutments	NHA	Substantially Equivalent	Jjgc Indústria E Comércia DE Materiais Dentários S.A.	accessdata.fda.gov
February 19, 2025	K243478	Straumann InLab Validated Workflow	NHA	Substantially Equivalent	Institut Straumann AG	accessdata.fda.gov
December 4, 2024	K242686	Neodent Implant System	NHA	Substantially Equivalent	Jjgc Indústria E Comércia DE Materiais Dentários S.A.	accessdata.fda.gov
August 23, 2024	K241492	Guided Surgery Kit Cases	KCT	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
May 2, 2024	K233857	Neodent Implant System Custom Abutments	NHA	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
December 13, 2023	K231803	Neodent Implant System - Zirconia Implant System	NHA	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
October 31, 2023	K232099	Neodent Implant System - GM Zygomatic Implant System	DZE	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
July 14, 2023	K222026	Neodent Implant System - Zirconia Implant System	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
July 7, 2023	K230804	Complement Kit Cases	KCT	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
June 23, 2023	K223638	Neodent Implant System - Helix Short Implant System	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
April 20, 2023	K223662	Neodent Implant System - Helix Short Surgical Kit Cases	KCT	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
September 6, 2022	K220251	Neodent Implant System - GM Narrow Implant System	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
April 13, 2022	K214051	Neodent Implant System-Helix NGM Compact Surgical Kit Cases	KCT	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
August 13, 2021	K210336	Neodent Implant System - Zirconia Implant System	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
August 6, 2021	K210320	ClearCorrect System	NXC	Substantially Equivalent	Clearcorrect, LLC	accessdata.fda.gov
August 2, 2021	K203542	Neodent Implant System - Mini Abutment 60°	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
July 6, 2021	K203309	NUVO CF Implant System	DZE	Substantially Equivalent	JJGC Indústria e Comércio de Materiais Dentários S.A.	accessdata.fda.gov
March 15, 2021	K203382	Neodent Implant System-Easy Pack	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
March 9, 2021	K203618	Neodent EasyGuide Kit Cases	KCT	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
January 29, 2021	K202282	Neodent Implant System - Zirconia Implant System	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
December 22, 2020	K201491	Neodent Implant System - Zirconia Implant System	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
November 24, 2020	K202515	NUVO Implant System NUVO Instrument Kit Cases	KCT	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
September 4, 2020	K201225	Neodent Implant System - GM Helix Implants 7.0	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
June 18, 2020	K193234	NUVO IF Implant System	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
April 28, 2020	K193592	Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
December 23, 2019	K190665	Neodent Instrument Kit Cases	KCT	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
December 19, 2019	K192229	Neodent Implant System- GM Titanium Base for Bridge	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
December 18, 2019	K192670	Neodent Instrument Kit Cases	KCT	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
December 5, 2019	K191191	Neodent Implant System - Temporary Abutments	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
November 9, 2019	K190958	Neodent Implant System	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
July 11, 2019	K190718	Zygomatic Implants	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
May 7, 2019	K182865	Neodent Instruments Kits	KCT	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
August 30, 2018	K180536	Neodent Implant System GM Line	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
April 20, 2018	K173902	Neodent Implant System GM Line	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
April 5, 2018	K171713	Neodent Instrument Kits	KCT	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
November 2, 2017	K170080	Neodent Implant System - CM Pro PEEK Abutment	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
July 14, 2017	K163194	Neodent Implant System - GM Line	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
September 16, 2016	K160964	Neodent Implant System - Titanium Base for CEREC	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	accessdata.fda.gov
April 15, 2016	K153624	Neodent Implant System	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
July 20, 2015	K141777	NEODENT IMPLANT SYSTEM	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
July 13, 2015	K150367	Neodent Implant System	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
June 15, 2015	K150199	Neodent Implant System	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
April 23, 2015	K150182	Neodent Implant System- CM Drive Implants	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
August 22, 2014	K133592	NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM	DZE	Substantially Equivalent	Neodent USA, Inc.	accessdata.fda.gov
February 25, 2014	K133696	NEODENT IMPLANT SYSTEM	NHA	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
February 24, 2014	K133510	NEODENT IMPLANT SYSTEM	DZE	Substantially Equivalent	Jj Industria E Comercio DE Materiais Dentarios SA	accessdata.fda.gov
May 17, 2013	K123022	NEODENT IMPLANT SYSTEM	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
February 23, 2011	K102769	NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE	OAT	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
February 14, 2011	K103084	NEODENT GRAFT SCREW	DZL	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
January 26, 2011	K101945	NEODENT IMPLANT SYSTEM	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov
August 2, 2010	K101207	NEODENT IMPLANT SYSTEM	DZE	Substantially Equivalent	Jjgc Industria E Comercio DE Materiais Dentarios S	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 11, 2021	88917	Class II	Terminated	GM Helix Acqua Implant 3.5x10, Article No.	3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.	accessdata.fda.gov
December 23, 2019	84709	Class II	Terminated	Neodent Tapered Guided Surgery Drill, Article No.. UDI 07899878030041. The device is a dental burr.	The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".	accessdata.fda.gov

Compare with other makers

Updated July 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. 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.