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 |