510(k) K820489
K820489 is an FDA 510(k) premarket notification submitted by Buffalo Dental Mfg. Co., Inc. for the device "ULTRAFINE TRAY ADHESIVE". The FDA issued a decision of Substantially Equivalent on March 19, 1982. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Buffalo Dental Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1982
- Date Received
- February 23, 1982
- 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