Data / Medical devices / United States / Dental Choice Holdings LLC
Dental Choice Holdings LLC: FDA-registered device maker in Louisville, KY, United States, 1 510(k) clearance
Dental Choice Holdings LLC is registered with the FDA (registration 3017968320) in Louisville, KY, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 23, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017968320
- Address
- 10100 Linn Station Road, Louisville, KY, United States, 40223
- Owner or operator
- Dental Choice Holdings LLC (10080343)
- Roles
- Specification developer
- First device listed
- January 27, 2021
- Registered through
- 2026
- Brand names listed
- BruxArmor, CustMbite Dental Guard, Disco Dreams, DreamEZ, Just Smile, Kloud, Protect the Crown, Resolve and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mouthguard, Over-The-Counter | OBR | U | Specification developer | 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 |
|---|---|---|---|---|---|---|
| August 23, 2019 | K183315 | CustMBite Dental Guard | OBR | Substantially Equivalent | Dental Choice Holdings, LLC | 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 23, 2022 | 90639 | Class II | Ongoing | CustMbite, Model Number CBT-SRS-UL | The device was marketed and sold in the US without FDA clearance. | accessdata.fda.gov |
Compare with other makers
Updated August 23, 2019. 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.