The following data is part of a premarket notification filed by North American Orthodontic Laboratories, Inc. with the FDA for Kromalgin Impression Material.
| Device ID | K964177 |
| 510k Number | K964177 |
| Device Name: | KROMALGIN IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | NORTH AMERICAN ORTHODONTIC LABORATORIES, INC. 200 E. PECAN ST. Gainsville, TX 76240 |
| Contact | Margaret H Christopherson |
| Correspondent | Margaret H Christopherson NORTH AMERICAN ORTHODONTIC LABORATORIES, INC. 200 E. PECAN ST. Gainsville, TX 76240 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-18 |
| Decision Date | 1996-12-30 |