The following data is part of a premarket notification filed by Almitech Inc. with the FDA for Almitech Inc. Dental Implant System.
| Device ID | K052733 |
| 510k Number | K052733 |
| Device Name: | ALMITECH INC. DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ALMITECH INC. 2643 BEDELL ST. Bellmore, NY 11710 |
| Contact | Alex Breytman |
| Correspondent | Alex Breytman ALMITECH INC. 2643 BEDELL ST. Bellmore, NY 11710 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-29 |
| Decision Date | 2005-12-22 |
| Summary: | summary |