K841011 is an FDA 510(k) clearance for the ELEVATOR - VARIOUS. This device is classified as a Curette, Periodontic (Class I — General Controls, product code EMS).
Submitted by Premier Dental Products Co. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1984, 98 days after receiving the submission on March 9, 1984.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K841011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1984 |
| Decision Date | June 15, 1984 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EMS — Curette, Periodontic |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4565 |