Roydent 103
by Roydent Dental Products Inc
Roydent 103 is a Class I device made by Roydent Dental Products Inc, listed in FDA GUDID since 7 Oct 2016 (UDI-DI D8091031), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD8091031 | Date7 Oct 2016 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Roydent
- Generic name
- Dental root surface conditioner
- Model / Ref / Catalog
- 103
- Primary DI / UDI-DI
- D8091031
- FDA product code
- EKL
- GMDN term
- Dental root surface conditioner
- Device class
- Class I
- Regulation number
- 872.3840
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 2.5 Milliliter