0817773021046 RS3513C
by Integrated Dental Systems, LLC
0817773021046 RS3513C is a Class II device made by Integrated Dental Systems, LLC, cleared under FDA 510(k) K180924 on 29 Mar 2019 and listed in FDA GUDID since 13 May 2020 (UDI-DI 00817773021046), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817773021046 | Date13 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180924 | Date29 Mar 2019 | StatusActive |
Official records
- AccessGUDID record 00817773021046
- FDA 510(k) database K180924
Across registries
- FDA 510(k) K180924 decided 29 Mar 2019 Active
- FDA GUDID UDI-DI 00817773021046 listed 13 May 2020 Listed
Timeline
- Cleared FDA 510(k) K180924
- Listed FDA GUDID 00817773021046
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- 0817773021046
- Generic name
- Dental bone matrix implant, metallic
- Model / Ref / Catalog
- RS3513C
- Primary DI / UDI-DI
- 00817773021046
- 510(k) Number
- FDA product code
- DZE
- GMDN term
- Dental bone matrix implant, metallic
- Device class
- Class II
- Regulation number
- 872.3640
- GUDID distribution status
- In Commercial Distribution
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