510(k) K861685
K861685 is an FDA 510(k) premarket notification submitted by Carlisle Laboratories, Inc. for the device "SUPERLON (UNILON) CARBOXYLATE CEMENT". The FDA issued a decision of Substantially Equivalent on May 19, 1986. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Carlisle Laboratories, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 1986
- Date Received
- May 2, 1986
- 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