K203618 is an FDA 510(k) clearance for the Neodent EasyGuide Kit Cases. 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 March 9, 2021, 88 days after receiving the submission on December 11, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6850.
| 510(k) Number | K203618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2020 |
| Decision Date | March 09, 2021 |
| Days to Decision | 88 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 |