The following data is part of a premarket notification filed by Dentaurum, Inc. with the FDA for Tomas Pin.
| Device ID | K042965 |
| 510k Number | K042965 |
| Device Name: | TOMAS PIN |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | DENTAURUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Contact | Thomas Lietz |
| Correspondent | Thomas Lietz DENTAURUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-27 |
| Decision Date | 2005-04-15 |
| Summary: | summary |