510(k) K123761
K123761 is an FDA 510(k) premarket notification submitted by Innovation Meditech GmbH for the device "VITA ENAMIC STAINS". The FDA issued a decision of Substantially Equivalent on March 1, 2013. The device falls under product code EBD (Coating, Filling Material, Resin), a Class II device regulated under 21 CFR 872.3310.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 2013
- Date Received
- December 7, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coating, Filling Material, Resin
- Device Class
- Class II
- Regulation Number
- 872.3310
- Review Panel
- DE
- Submission Type