Dental Choice Holdings LLC

Louisville, KY, US

DENTAL CHOICE HOLDINGS LLC appears in FDA device records in Louisville, KY. FDA records list 2 510(k) clearances between 2019-08-23 and 2022-10-27, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

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

FDA records under these names

1 name

FDA records resolved to Dental Choice Holdings LLC 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.

Dental Choice Holding Llcenforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Dental Choice Holdings LLC between 2019 and 2022. The busiest year on record is 2019, with 1. The most recent is 2022, with 1.

Clearances by year, as a table

510(k) clearance decisions for Dental Choice Holdings LLC, by decision year
Year	Clearances
2019	1
2022	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K221322	CUSTMBITE Snoring System	LRK	Substantially Equivalent	2022-10-27
K183315	CustMBite Dental Guard	OBR	Substantially Equivalent	2019-08-23

Registered establishments

FDA registered establishments for Dental Choice Holdings LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3017968320	3017968320	DENTAL CHOICE HOLDINGS LLC	10100 Linn Station Road, Louisville, KY 40223 US	2026	OBR

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-1494-2022	CustMbite, Model Number CBT-SRS-UL	The device was marketed and sold in the US without FDA clearance.	Class II	2022-05-23	Open, Classified

Verification record

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