510(k) K813532
K813532 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "CUTTERBOND ZINC PHOSPHATE CEMENT". The FDA issued a decision of Substantially Equivalent on March 2, 1982. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1982
- Date Received
- December 17, 1981
- 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