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 |