The following data is part of a premarket notification filed by Addent, Inc. with the FDA for Calset Composite Heater.
| Device ID | K061395 |
| 510k Number | K061395 |
| Device Name: | CALSET COMPOSITE HEATER |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | ADDENT, INC. 43 MIRY BROOK RD. Danbury, CT 06810 |
| Contact | Joshua Friedman |
| Correspondent | Joshua Friedman ADDENT, INC. 43 MIRY BROOK RD. Danbury, CT 06810 |
| Product Code | EBZ |
| Subsequent Product Code | EEG |
| Subsequent Product Code | EFC |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-19 |
| Decision Date | 2006-06-23 |
| Summary: | summary |