Cleared Traditional

Neodent Implant System-Helix NGM Compact Surgical Kit Cases

K214051 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · General Hospital

Apr 2022

Decision

107d

Days

Class 2

Risk

About This 510(k) Submission

K214051 is an FDA 510(k) clearance for the Neodent Implant System-Helix NGM Compact Surgical Kit Cases, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. (Curitiba, BR). The FDA issued a Cleared decision on April 13, 2022, 107 days after receiving the submission on December 27, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K214051 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2021
Decision Date	April 13, 2022
Days to Decision	107 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850