K864307 is an FDA 510(k) clearance for the MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI). This device is classified as a Syringe, Periodontic, Endodontic, Irrigating (Class I - General Controls, product code EIC).
Submitted by Smith & Nephew, Inc. (Chicago, US). The FDA issued a Cleared decision on November 18, 1986, 15 days after receiving the submission on November 3, 1986.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K864307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 1986 |
| Decision Date | November 18, 1986 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EIC — Syringe, Periodontic, Endodontic, Irrigating |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |