Cleared Traditional

K993255 - BIOSONIC UC-70 STERILIZABLE INSTRUMENT ...

K993255 is an FDA 510(k) clearance for BIOSONIC UC-70 STERILIZABLE INSTRUMENT ..., manufactured by Coltene/Whaledent, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K993255 · Coltene/Whaledent, Inc. · General Hospital
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Dec 1999
Decision
69d
Days
Class 2
Risk

K993255 is an FDA 510(k) clearance for the BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Coltene/Whaledent, Inc. (Mahwah, US). The FDA issued a Cleared decision on December 6, 1999 after a review of 69 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 Coltene/Whaledent, Inc. devices

FDA 510(k) Submission Details - K993255

510(k) Number K993255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1999
Decision Date December 06, 1999
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 163
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K993255.
ALLEGIANCE GENESIS CONTAINER SYSTEM
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BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
K993871 · Allegiance Healthcare Corp. · Apr 2000
PARAPOST SYSTEM STERILIZABLE ORGANIZER
K993835 · Coltene/Whaledent, Inc. · Dec 1999
BIOSHIELD EXPRESS STERILIZATION WRAP
K983719 · Allegiance Healthcare Corp. · Aug 1999
SUPRASHIELD EXPRESS STERILIZATION WRAP
K990300 · Allegiance Healthcare Corp. · Feb 1999
CPR DRESSING CHANGE TRAY
K960206 · Custom Pack Reliability · Apr 1996