510(k) K883698
K883698 is an FDA 510(k) premarket notification submitted by E&D Dental Manufacturing Co. for the device "ZINC OXIDE EUGENOL TEMPORARY CEMENT". The FDA issued a decision of Substantially Equivalent on November 29, 1988. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. E&D Dental Manufacturing Co. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1988
- Date Received
- August 30, 1988
- 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