Viscostat Clear
510(k) K123215
Viscostat Clear is a medical device (FDA unclassified; FDA product code MVL, Cord, Retraction) made by Ultradent Products, Inc., cleared under FDA 510(k) K123215 on 5 Feb 2013 and registered in EUDAMED, active as of 22 Oct 2026.
Active
CE MDR 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK123215 | Date5 Feb 2013 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- FDA 510(k) K123215 decided 5 Feb 2013 Active
- EUDAMED Active
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- MVL
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
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