510(k) K945220
K945220 is an FDA 510(k) premarket notification submitted by Buffalo Dental Mfg. Co., Inc. for the device "AMALGAM CARRIER". The FDA issued a decision of Substantially Equivalent on January 11, 1995. The device falls under product code EKI (Carrier, Amalgam, Operative), a Class I device regulated under 21 CFR 872.4565. Buffalo Dental Mfg. Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1995
- Date Received
- October 26, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carrier, Amalgam, Operative
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type