K821625 is an FDA 510(k) clearance for the ENDODONTIC PAPERPOINTS. This device is classified as a Point, Paper, Endodontic (Class I - General Controls, product code EKN).
Submitted by Roeko (Mchenry, US). The FDA issued a Cleared decision on June 14, 1982, 12 days after receiving the submission on June 2, 1982.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3830.
| 510(k) Number | K821625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1982 |
| Decision Date | June 14, 1982 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EKN — Point, Paper, Endodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3830 |