510(k) K101064
K101064 is an FDA 510(k) premarket notification submitted by Bredent GmbH & Co. KG for the device "BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P". The FDA issued a decision of Substantially Equivalent on September 14, 2010. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590. Bredent GmbH & Co. KG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2010
- Date Received
- April 16, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Denture, Plastic, Teeth
- Device Class
- Class II
- Regulation Number
- 872.3590
- Review Panel
- DE
- Submission Type