Dentalez, Inc., Stardental Division

Lancaster, PA, US

DENTALEZ, INC., STARDENTAL DIVISION appears in FDA device records in Lancaster, PA. FDA records list 2 510(k) clearances between 2024-09-19 and 2026-01-12, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 7 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 7
Registered establishments: 1

FDA records under these names

4 names

FDA records resolved to Dentalez, Inc., Stardental Division carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Den-Tal-Ez Inc,Star Dental Divrecall
Dental EZ Group Star Dental Divisionenforcement report, recall
Dental EZ Stardental Divisionenforcement report, recall
Stardental Divisionrecall

510(k) clearance history

FDA records hold 2 510(k) clearances for Dentalez, Inc., Stardental Division between 2024 and 2026. The busiest year on record is 2024, with 1. The most recent is 2026, with 1.

Clearances by year, as a table

510(k) clearance decisions for Dentalez, Inc., Stardental Division, by decision year
Year	Clearances
2024	1
2026	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K251701	Star E900 Electric System	EBW	Substantially Equivalent	2026-01-12
K240183	Star E900 Handpiece Series	EGS	Substantially Equivalent	2024-09-19

Registered establishments

FDA registered establishments for Dentalez, Inc., Stardental Division, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
2520265	2520265	DENTALEZ, INC., STARDENTAL DIVISION	1816 Colonial Village Ln, Lancaster, PA 17601 US	2026	DZP EBW EFB EGS EIA EJE EKB EKC EKK EKR and 4 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2178-2024	Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 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 incisors and deep local pockets.	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	Class II	2024-05-30	Open, Classified
Z-2177-2024	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 incisors and deep local pockets.	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	Class II	2024-05-30	Open, Classified
Z-2078-2014	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 range of 100 to 5000 rpm capability.	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.	Class II	2014-06-13	Terminated
Z-1522-2013	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.	Class II	2013-05-28	Terminated
Z-2354-2010	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.		2010-08-11	Terminated
Z-0313-2007	Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.	End cap component can disassemble.		2006-12-01	Terminated
Z-1272-02	Portable HDX Intraoral Dental X-Ray. Extraoral Source X-ray System. Part number 300020	problems with product label		2003-05-16	Terminated

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain