510(k) K130076
K130076 is an FDA 510(k) premarket notification submitted by Merz Dental GmbH for the device "PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS". The FDA issued a decision of Substantially Equivalent on August 22, 2013. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. Merz Dental GmbH has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2013
- Date Received
- January 14, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type