Cleared Traditional

K022971 - MICROHYBRID 11

K022971 is an FDA 510(k) clearance for MICROHYBRID 11, 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 80-day FDA review.

K022971 · Ab Ardent · Dental device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Nov 2002

Decision

80d

Days

Class 2

Risk

K022971 is an FDA 510(k) clearance for the MICROHYBRID 11. 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 25, 2002 after a review of 80 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 - K022971

510(k) Number	K022971 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 06, 2002
Decision Date	November 25, 2002
Days to Decision	80 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

48d faster than avg

Panel avg: 128d · This submission: 80d

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 K022971.

4 SEASONS

K024094 · Ivoclar Vivadent, Inc. · Feb 2003

GRADIA DIRECT

K023814 · GC America, Inc. · Jan 2003

SCULPTURE PLUS NANO-HYBRID COMPOSITE

K023742 · Pentron Laboratory Technologies · Jan 2003

MICROFILL 13

K022972 · Ab Ardent · Nov 2002

MICROHYBRID 12

K022974 · Ab Ardent · Nov 2002

ETCHING 15

K022975 · Ab Ardent · Nov 2002

FDA 510(k) Resources - Dental

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K022971

Ab Ardent

Tonawanda, NY · US

CLYDE E INGERSOLL

Regulatory profile

13 submissions 13 cleared

100% clearance rate · Active in Dental

View all devices by Ab Ardent →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: November 25, 2002. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 176,325

Regulatory data since 1976

FDA monthly sync October 7, 2026