Cleared Traditional

K821895 - AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR

K821895 is an FDA 510(k) clearance for AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR, manufactured by American Midwest. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K821895 · American Midwest · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1982
Decision
18d
Days
Class 2
Risk

K821895 is an FDA 510(k) clearance for the AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by American Midwest (Mchenry, US). The FDA issued a Cleared decision on July 16, 1982 after a review of 18 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.

View all American Midwest devices

FDA 510(k) Submission Details - K821895

510(k) Number K821895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1982
Decision Date July 16, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 128d · This submission: 18d
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 821
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K821895.
GAMMA LIGHT CURING DENTAL RESTORATIVE
K823185 · Johnson & Johnson Professionals, Inc. · Nov 1982
AURAFILL* DENTAL RESTORATIVE
K822450 · Johnson & Johnson Professionals, Inc. · Sep 1982
VISIO-OPAQUER
K822453 · Espe GmbH (Us) · Sep 1982
ZEON COMPOSITE RESIN LIGHT CURE SYS
K820028 · National Patent Development Corp. · Mar 1982
SYBRON/KERR COMMAND
K820182 · Sybron Corp. · Mar 1982
ESTILUX POSTERIOR XR
K813568 · Kulzer, Inc. · Jan 1982