K171713 is an FDA 510(k) clearance for the Neodent Instrument Kits. This device is classified as a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II - Special Controls, product code KCT).
Submitted by Jjgc Industria E Comercio DE Materiais Dentarios S.A. (Curitiba, BR). The FDA issued a Cleared decision on April 5, 2018, 300 days after receiving the submission on June 9, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K171713 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 2017 |
| Decision Date | April 05, 2018 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6850 |