The following data is part of a premarket notification filed by Foremost Dental Llc. with the FDA for Fiber-metal Post.
Device ID | K060075 |
510k Number | K060075 |
Device Name: | FIBER-METAL POST |
Classification | Post, Root Canal |
Applicant | FOREMOST DENTAL LLC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
Contact | Pamela Papineau |
Correspondent | Pamela Papineau FOREMOST DENTAL LLC. 5 WHITCOMB AVENUE Ayer, MA 01432 |
Product Code | ELR |
CFR Regulation Number | 872.3810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-10 |
Decision Date | 2006-03-30 |
Summary: | summary |