510(k) K911285
K911285 is an FDA 510(k) premarket notification submitted by Pulpdent Corp. for the device "PULPDENT POLYAMIDE DENTIN LINER". The FDA issued a decision of Substantially Equivalent on October 9, 1991. The device falls under product code EME (Punch, Biopsy, Surgical), a Class I device regulated under 21 CFR 872.4565. Pulpdent Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 1991
- Date Received
- March 19, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Punch, Biopsy, Surgical
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type