510(k) K060994
K060994 is an FDA 510(k) premarket notification submitted by Heraeus Kulzer, Inc. for the device "MONDIAL". The FDA issued a decision of Substantially Equivalent on May 22, 2006. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590. Heraeus Kulzer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2006
- Date Received
- April 11, 2006
- 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