510(k) K781281
K781281 is an FDA 510(k) premarket notification submitted by Star Dental Mfg. Co. for the device "CEMENT, DENTAL/CAVITY LINER". The FDA issued a decision of Substantially Equivalent on August 21, 1978. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Star Dental Mfg. Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1978
- Date Received
- July 26, 1978
- 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