FDA Medical Device Recalls (openFDA)
Dental Choice Holding Llc: CustMbite, Model Number CBT-SRS-UL
- Recall number
- Z-1494-2022
- Recalling firm
- Dental Choice Holding Llc
- Product
- CustMbite, Model Number CBT-SRS-UL
- Status
- Open, Classified
- Initiated
- 2022-05-23
- Posted
- not on file
- Terminated
- not on file
- Reason
- The device was marketed and sold in the US without FDA clearance.
- Root cause
- No Marketing Application
- Action
- Firm began notifying customers via recall letters on 5/23/22 and 6/6/22. A second round of letters was sent on 6/30/22 non-responding customers. Customers are instructed to cease use of the product and to discard it immediately. The firm will provide a full refund to affected customers. To receive a full refund of the purchase price, please contact Dental Choice Holdings Customer Service between the hours of 9am and 5pm Eastern Standard Time at 1-(855)-253-4680 or send an email to customerservice@custmbite.com.
- Quantity
- 708
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI-DI: N/a Lot codes: SS-J21287-200-1021, SS-K21333-510-1121, SS-B22040-305-0222
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRK
- Firm FEI
- 3017968320
- Firm city
- Louisville
- Firm state
- KY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28