The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Dentalon.
| Device ID | K831077 |
| 510k Number | K831077 |
| Device Name: | DENTALON |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | KULZER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-04 |
| Decision Date | 1983-09-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DENTALON 74392001 1934568 Live/Registered |
KULZER GMBH 1993-04-26 |