Cleared Traditional

K192670 - Neodent Instrument Kit Cases

K192670 is the FDA 510(k) clearance for Neodent Instrument Kit Cases by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K192670 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · General Hospital
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Optimized for regulatory review, auditing and printing
Dec 2019
Decision
84d
Days
Class 2
Risk

K192670 is an FDA 510(k) clearance for the Neodent Instrument Kit Cases. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Jjgc Industria E Comercio DE Materiais Dentarios S.A. (Curitiba, BR). The FDA issued a Cleared decision on December 18, 2019 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Jjgc Industria E Comercio DE Materiais Dentarios S.A. devices

Submission Details

510(k) Number K192670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2019
Decision Date December 18, 2019
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 161
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K192670.
Avinent Surgical Tray
K191566 · Avinent Implant System S.L.U. · Mar 2020
Neodent Instrument Kit Cases
K190665 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Dec 2019
EZ-TRAX Containment Device
K192487 · K1 Medical, LLC · Dec 2019
Straumann Modular Cassette
K191522 · Institut Straumann AG · Dec 2019
Pivot System Sterilization case
K181845 · Rp Medical, Inc. · Nov 2019
MTS225 and MTS300 Multiple Tray Sterilization Systems
K190541 · Pmbs, LLC · Nov 2019