510(k) K952930
K952930 is an FDA 510(k) premarket notification submitted by Confi-Dental Products Co. for the device "DENTRAY II PLUS TRAY ADHESIVE". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Confi-Dental Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1995
- Date Received
- June 19, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type