Data / Medical devices / United States / Dentalez, Inc., Stardental Division

Dentalez, Inc., Stardental Division: FDA-registered device maker in Lancaster, PA, United States, 15 510(k) clearances

Name: Dentalez, Inc., Stardental Division FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dentalez, Inc., Stardental Division is registered with the FDA (registration 2520265) in Lancaster, PA, United States. It lists 14 device types. The FDA files 15 510(k) clearances under its listings, the newest dated January 12, 2026. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 2520265
Address: 1816 Colonial Village Ln, Lancaster, PA, United States, 17601
Owner or operator: DENTALEZ, INC. (2513147)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: September 30, 1992
Registered through: 2027
Brand names listed: 2-line Non-Fiber Optic Swivel, 4-line Non-Fiber Optic Swivel, 430 SW 45 Handpiece - 265822, 430 SWL 45 Handpiece - 265821, 430 Series Lube Free High Speed Handpieces - 266153, 266182, 262057, 262052, 268840, 264450, 268841, 430 Series Lubricated High Speed Handpieces - 266154, 266183, 264451, 268861, 264951, 264952, 430 Torque HP, 5-Hole Fiber Optic Swivel and more

Devices it lists

Device	Product code	Class	Role	Source
Controller, Foot, Handpiece And Cord	EBW	1	Manufacturer	accessdata.fda.gov
Curette, Periodontic	EMS	1	Manufacturer	accessdata.fda.gov
Excavator, Dental, Operative	EKC	1	Manufacturer	accessdata.fda.gov
Explorer, Operative	EKB	1	Manufacturer	accessdata.fda.gov
Frame, Rubber Dam	EJE	1	Specification developer	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Repackager or relabeler	accessdata.fda.gov
Instrument, Diamond, Dental	DZP	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Manufacturer	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Manufacturer	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Manufacturer	accessdata.fda.gov
Spreader, Pulp Canal Filling Material, Endodontic	EKK	1	Manufacturer	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Repackager or relabeler	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
January 12, 2026	K251701	Star E900 Electric System	EBW	Substantially Equivalent	Dentalez, Inc., Stardental Division	accessdata.fda.gov
September 19, 2024	K240183	Star E900 Handpiece Series	EGS	Substantially Equivalent	Dentalez, Inc., Stardental Division	accessdata.fda.gov
January 6, 2020	K192412	SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece	EFB	Substantially Equivalent	Dentalez, Inc.	accessdata.fda.gov
August 15, 2017	K163483	PANA SPRAY Plus	EFB	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
April 8, 2016	K153411	430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece	EFB	Substantially Equivalent	Dentalez, Inc.	accessdata.fda.gov
January 31, 2014	K132356	SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST	EGS	Substantially Equivalent	Scican GmbH	accessdata.fda.gov
September 25, 2013	K130455	430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES	EFB	Substantially Equivalent	Dentalez Group, Stardental Division	accessdata.fda.gov
September 12, 2013	K131578	IPROPHY MOBILE	EKX	Substantially Equivalent	Nakanishi, Inc.	accessdata.fda.gov
January 23, 2012	K113301	CONCENPIECE,HIGH-SPEED HANDPIECE SERIES	EFB	Substantially Equivalent	Dentalez, Inc.	accessdata.fda.gov
July 24, 2009	K090937	E-STATIS 40 SYSTEM	EBW	Substantially Equivalent	Scican , Ltd.	accessdata.fda.gov
June 15, 2007	K070869	PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422	EFB	Substantially Equivalent	Dentalez, Inc.	accessdata.fda.gov
January 8, 1999	K983574	STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS	EGS	Substantially Equivalent	Dentalez Group	accessdata.fda.gov
October 22, 1998	K982593	LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE	EFB	Substantially Equivalent	Dentalez Group	accessdata.fda.gov
December 29, 1994	K944271	DENTAL OPERATIVE UNIT ACCESORIES	EIA	Substantially Equivalent	Dci Intl.	accessdata.fda.gov
April 21, 1988	K881253	ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW	ELC	Substantially Equivalent	Dentalez Group	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
May 30, 2024	94783	Class II	Ongoing	Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisor	Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury	accessdata.fda.gov
June 13, 2014	68609	Class II	Terminated	Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed rang	The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.	accessdata.fda.gov
May 28, 2013	65283	Class II	Terminated	StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.	Recall was initiated because a manufacturing issue was found that prevented the diamond coating from adhering properly to the shank of the diamond bur for these lots.	accessdata.fda.gov
August 11, 2010	56489	Not yet classified	Terminated	Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free	The housing of 5K motor is labeled as a 20K motor.	accessdata.fda.gov
December 1, 2006	36920	Not yet classified	Terminated	Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.	End cap component can disassemble.	accessdata.fda.gov
May 16, 2003	26413	Not yet classified	Terminated	Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020	problems with product label	accessdata.fda.gov

Compare with other makers

Updated January 12, 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.