The following data is part of a premarket notification filed by American Tooth Industries with the FDA for Alginmax, Orthochrome.
| Device ID | K963205 |
| 510k Number | K963205 |
| Device Name: | ALGINMAX, ORTHOCHROME |
| Classification | Material, Impression |
| Applicant | AMERICAN TOOTH INDUSTRIES 1819 SO. MAY ST. 2F Chicago, IL 60608 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer AMERICAN TOOTH INDUSTRIES 1819 SO. MAY ST. 2F Chicago, IL 60608 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-09 |
| Decision Date | 1996-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190746008146 | K963205 | 000 |
| 00190746008139 | K963205 | 000 |
| 00190746008122 | K963205 | 000 |
| 00190746008115 | K963205 | 000 |