K880827 is an FDA 510(k) clearance for the ACCUTEK PERIODONTAL PROBE. This device is classified as a Probe, Periodontic (Class I - General Controls, product code EIX).
Submitted by Sweet Micro Systems, Inc. (Cranston, US). The FDA issued a Cleared decision on April 12, 1988, 42 days after receiving the submission on March 1, 1988.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K880827 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 1988 |
| Decision Date | April 12, 1988 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIX — Probe, Periodontic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |