Cleared Traditional

K983223 - DENTAL STERLIZATION TRAY/CASSETTE

K983223 is an FDA 510(k) clearance for DENTAL STERLIZATION TRAY/CASSETTE, manufactured by Brasseler USA I, L.P.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K983223 · Brasseler USA I, L.P. · General Hospital
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Jan 1999
Decision
122d
Days
Class 2
Risk

K983223 is an FDA 510(k) clearance for the DENTAL STERLIZATION TRAY/CASSETTE. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Brasseler USA I, L.P. (Atlanta, US). The FDA issued a Cleared decision on January 14, 1999 after a review of 122 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 Brasseler USA I, L.P. devices

FDA 510(k) Submission Details - K983223

510(k) Number K983223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1998
Decision Date January 14, 1999
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 129d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
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 Peers - FRG Wrap, Sterilization

All 195
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K983223.
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K972138 · Carr Metal Products, Inc. · Nov 1997
SECURE-WRAP (TM) STERILIZATION WRAP
K971483 · American Threshold Industries, Inc. · Jun 1997