K843018 is an FDA 510(k) clearance for the FLEXI-POST. This device is classified as a Setter, Band, Orthodontic (Class I - General Controls, product code ECR).
Submitted by Essential Dental Systems, Inc. (Walker, US). The FDA issued a Cleared decision on September 27, 1984, 57 days after receiving the submission on August 1, 1984.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K843018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1984 |
| Decision Date | September 27, 1984 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | ECR - Setter, Band, Orthodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |