Cleared Traditional

K861546 - REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT

K861546 is an FDA 510(k) clearance for REPLICA-F VISIBLE LIGHT-CURED ANT/POST ..., manufactured by Macrochem Corp.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K861546 · Macrochem Corp. · Dental device
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May 1986
Decision
26d
Days
Class 2
Risk

K861546 is an FDA 510(k) clearance for the REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Macrochem Corp. (Woburn, US). The FDA issued a Cleared decision on May 21, 1986 after a review of 26 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 Macrochem Corp. devices

FDA 510(k) Submission Details - K861546

510(k) Number K861546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1986
Decision Date May 21, 1986
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 128d · This submission: 26d
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 817
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K861546.
V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT
K862648 · Scientific Pharmaceuticals, Inc. · Jul 1986
RESTOR (COMET)*DENTAL RESTORATIVE
K861833 · Johnson & Johnson Professionals, Inc. · Jul 1986
SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE
K861899 · 3M Company · Jun 1986
P-50 LIGHT CURED RESIN BONDED CERAMIC
K861740 · 3M Company · May 1986
BISCO'S PORCELAIN VENEER SYSTEM
K861148 · Bisco, Inc. · Apr 1986
PHOTO CLEARFIL OPAQUER
K860708 · Kuraray Co. · Apr 1986