The following data is part of a premarket notification filed by Carlisle Laboratories, Inc. with the FDA for Superlon (unilon) Carboxylate Cement.
Device ID | K861685 |
510k Number | K861685 |
Device Name: | SUPERLON (UNILON) CARBOXYLATE CEMENT |
Classification | Cement, Dental |
Applicant | CARLISLE LABORATORIES, INC. 404 DOUGHTY BLVD. Inwood, NY 11696 |
Contact | Michael Stehn |
Correspondent | Michael Stehn CARLISLE LABORATORIES, INC. 404 DOUGHTY BLVD. Inwood, NY 11696 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-02 |
Decision Date | 1986-05-19 |