Soleil 5128-792
Soleil 5128-792 is a Class II device made by Benco Dental Supply Co., cleared under FDA 510(k) K163447 on 20 Jun 2017 and listed in FDA GUDID since 2 Oct 2017 (UDI-DI D74451287920), active as of 23 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 | NumberD74451287920 | Date2 Oct 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163447 | Date20 Jun 2017 | StatusActive |
Official records
- FDA 510(k) database K163447
Across registries
- FDA 510(k) K163447 decided 20 Jun 2017 Active
- FDA GUDID UDI-DI D74451287920 listed 2 Oct 2017 Listed
Timeline
- Cleared FDA 510(k) K163447
- Listed FDA GUDID D74451287920
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Soleil
- Generic name
- Instrument/equipment drape, single-use, non-sterile
- Model / reference
- 5128-792
- Primary DI / UDI-DI
- D74451287920
- 510(k) Number
- FDA product code
- PEM
- GMDN term
- Instrument/equipment drape, single-use, non-sterile
- Device class
- Class II
- Regulation number
- 878.4370
- GUDID distribution status
- In Commercial Distribution
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