VisCalor 6108
by VOCO GmbH
VisCalor 6108 is a Class II device made by VOCO GmbH, cleared under FDA 510(k) K201307 on 8 Jul 2020 (1 earlier submission) and listed in FDA GUDID since 8 Jan 2021 (UDI-DI E22161081), 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 | NumberE22161081 | Date8 Jan 2021 | StatusListed |
| United States | FDA 510(k) | NumberK201307 | Date8 Jul 2020 | StatusActive |
Official records
- FDA 510(k) database K201307
- FDA 510(k) database K130486
Across registries
- FDA 510(k) K201307 decided 8 Jul 2020 Active
- FDA GUDID UDI-DI E22161081 listed 8 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K130486
- Cleared FDA 510(k) K201307
- Listed FDA GUDID E22161081
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VisCalor
- Generic name
- Dentine bonding agent/set
- Model / Ref / Catalog
- 6108
- Primary DI / UDI-DI
- E22161081
- FDA product code
- EMA, KLE, EBF
- GMDN term
- Dentine bonding agent/set
- Device class
- Class II
- Regulation number
- 872.3275, 872.3200, 872.3690
- GUDID distribution status
- In Commercial Distribution
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