The following data is part of a premarket notification filed by Essential Dental Systems, Inc. with the FDA for Flexi-post.
Device ID | K843018 |
510k Number | K843018 |
Device Name: | FLEXI-POST |
Classification | Setter, Band, Orthodontic |
Applicant | ESSENTIAL DENTAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ECR |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-01 |
Decision Date | 1984-09-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FLEXI-POST 73421558 1304878 Live/Registered |
Essential Dental Systems, Inc. 1983-04-14 |
FLEXI-POST 71229976 0220043 Dead/Expired |
MILLER, HENRY C. 1926-04-10 |