Cleared Traditional

K022975 - ETCHING 15

K022975 is an FDA 510(k) clearance for ETCHING 15, manufactured by Ab Ardent. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K022975 · Ab Ardent · Dental device
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Nov 2002
Decision
77d
Days
Class 2
Risk

K022975 is an FDA 510(k) clearance for the ETCHING 15. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ab Ardent (Tonawanda, US). The FDA issued a Cleared decision on November 22, 2002 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory 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.

FDA 510(k) Submission Details - K022975

510(k) Number K022975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2002
Decision Date November 22, 2002
Days to Decision 77 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 128d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 Dental devices follow this clearance model.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 878
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K022975.
MICROHYBRID 11
K022971 · Ab Ardent · Nov 2002
MICROFILL 13
K022972 · Ab Ardent · Nov 2002
MICROHYBRID 12
K022974 · Ab Ardent · Nov 2002
PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
K022675 · Prime Dental Manufacturing, Inc. · Nov 2002
CLEARFIL AP-X PLT
K023002 · Kuraray Medical, Inc. · Oct 2002
MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
K021250 · Handpiece Unlimited · Oct 2002
K022975 · ETCHING 15
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