The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Root Canal Post.
Device ID | K802515 |
510k Number | K802515 |
Device Name: | ROOT CANAL POST |
Classification | Post, Root Canal |
Applicant | UNITEK CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ELR |
CFR Regulation Number | 872.3810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-15 |
Decision Date | 1980-11-12 |