The following data is part of a premarket notification filed by Dentaurum with the FDA for Tomas Pin Sd 6, 8, And 10 Mm.
Device ID | K062733 |
510k Number | K062733 |
Device Name: | TOMAS PIN SD 6, 8, AND 10 MM |
Classification | Implant, Endosseous, Orthodontic |
Applicant | DENTAURUM 10 PHEASANT RUN Newtown, PA 18940 |
Contact | Charles R Bell |
Correspondent | Charles R Bell DENTAURUM 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 | 2006-09-13 |
Decision Date | 2006-11-09 |
Summary: | summary |