510(k) K912989
K912989 is an FDA 510(k) premarket notification submitted by Wilde-USA, Inc. for the device "PLANUSTAR AND DENS NOBILIS DENTURE TEETH". The FDA issued a decision of Substantially Equivalent on August 16, 1991. The device falls under product code EMI (File, Bone, Surgical), a Class I device regulated under 21 CFR 872.4565. Wilde-USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 1991
- Date Received
- July 8, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- File, Bone, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type