510(k) K780528
K780528 is an FDA 510(k) premarket notification submitted by Premier Dental Products Co. for the device "PREMIER CARVERS, STYLE #21C & 21D". The FDA issued a decision of Substantially Equivalent on April 19, 1978. The device falls under product code EKH (Carver, Dental Amalgam, Operative), a Class I device regulated under 21 CFR 872.4565. Premier Dental Products Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1978
- Date Received
- April 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carver, Dental Amalgam, Operative
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type