The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for Den-mat Dentin Bonding Agent.
| Device ID | K801216 |
| 510k Number | K801216 |
| Device Name: | DEN-MAT DENTIN BONDING AGENT |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DEN-MAT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-21 |
| Decision Date | 1980-05-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813032245101B0 | K801216 | 000 |
| D8130304129010 | K801216 | 000 |
| D8130304129020 | K801216 | 000 |
| D8130304510100 | K801216 | 000 |
| D8130311451000 | K801216 | 000 |
| D813031145110B0 | K801216 | 000 |
| D813031145201B0 | K801216 | 000 |
| D8130311453000 | K801216 | 000 |
| D8130311457000 | K801216 | 000 |
| D8130311481000 | K801216 | 000 |
| D8130304119000 | K801216 | 000 |