Cleared Traditional

Neodent Implant System-Helix NGM Compact Surgical Kit Cases (K214051) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K214051 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2022
Decision
107d
Days
Class 2
Risk

K214051 is an FDA 510(k) clearance for the Neodent Implant System-Helix NGM Compact Surgical Kit Cases. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

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 after a review of 107 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. devices

Submission Details

510(k) Number K214051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 129d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Straumann USA, LLC
Jennifer M. Jackson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 139
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K214051.
SteriCUBE® Multiple Tray Sterilization Systems
K222328 · Stericube, LLC · Sep 2022
Surgical and Prosthetic Trays
K220791 · Dentsply Sirona · May 2022
SteriTite Container System with MediTray Products
K212711 · Case Medical, Inc. · Apr 2022
Surgical Trays
K212281 · Dentsply Sirona, Inc. · Mar 2022
Southern Implants Instrument Trays
K210923 · Southern Implants (Pty), Ltd. · Mar 2022
Sterisystem Dry-Base Instrument Tray
K203177 · O&M Halyard, Inc. · Jan 2022