Plasdent IC-085
Plasdent IC-085 is a Class II device made by Plasdent Corp., cleared under FDA 510(k) K201604 on 23 Dec 2020 and listed in FDA GUDID since 19 Jul 2022 (UDI-DI D832IC0851), 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 | NumberD832IC0851 | Date19 Jul 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201604 | Date23 Dec 2020 | StatusActive |
Official records
- FDA 510(k) database K201604
Across registries
- FDA 510(k) K201604 decided 23 Dec 2020 Active
- FDA GUDID UDI-DI D832IC0851 listed 19 Jul 2022 Listed
Timeline
- Cleared FDA 510(k) K201604
- Listed FDA GUDID D832IC0851
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Plasdent
- Generic name
- Medical equipment/instrument drape, single-use
- Model / Ref / Catalog
- IC-085
- Primary DI / UDI-DI
- D832IC0851
- 510(k) Number
- FDA product code
- PEM
- GMDN term
- Medical equipment/instrument drape, single-use
- Device class
- Class II
- Regulation number
- 878.4370
- GUDID distribution status
- In Commercial Distribution
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