510(k) K841490
K841490 is an FDA 510(k) premarket notification submitted by Buffalo Dental Mfg. Co., Inc. for the device "POLYSULFIDE CUSTOM TRAY MATERIAL". The FDA issued a decision of Substantially Equivalent on June 27, 1984. 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
- June 27, 1984
- Date Received
- April 10, 1984
- 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