K800827 is an FDA 510(k) clearance for the PREMIER ABSORBENT POINTS. This device is classified as a Point, Paper, Endodontic (Class I - General Controls, product code EKN).
Submitted by Premier Dental Products Co. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1980, 15 days after receiving the submission on April 14, 1980.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3830.
| 510(k) Number | K800827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1980 |
| Decision Date | April 29, 1980 |
| Days to Decision | 15 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 |