510(k) K802819
K802819 is an FDA 510(k) premarket notification submitted by Espe Dental Products for the device "KETAC-CEM IN REF. TO K802048". The FDA issued a decision of Substantially Equivalent on November 24, 1980. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Espe Dental Products has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1980
- Date Received
- November 7, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type