510(k) K984128
K984128 is an FDA 510(k) premarket notification submitted by Davis Schottlander & Davis, Ltd. for the device "ENIGMA DENTURE TEETH". The FDA issued a decision of Substantially Equivalent on February 9, 1999. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590. Davis Schottlander & Davis, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1999
- Date Received
- November 18, 1998
- 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