K850906 is an FDA 510(k) clearance for the TACTILE PLUS DENTAL ELEVATORS. This device is classified as a Elevator, Surgical, Dental (Class I - General Controls, product code EMJ).
Submitted by Ipco Corp. (White Plains, US). The FDA issued a Cleared decision on April 12, 1985, 38 days after receiving the submission on March 5, 1985.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K850906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1985 |
| Decision Date | April 12, 1985 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EMJ — Elevator, Surgical, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |