Cleared Traditional

K832062 - ADAPTIC*FAST SET DENTAL RESTORATIVE

K832062 is an FDA 510(k) clearance for ADAPTIC*FAST SET DENTAL RESTORATIVE, manufactured by Johnson & Johnson Professionals, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K832062 · Johnson & Johnson Professionals, Inc. · Dental device
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Aug 1983
Decision
65d
Days
Class 2
Risk

K832062 is an FDA 510(k) clearance for the ADAPTIC*FAST SET DENTAL RESTORATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on August 31, 1983 after a review of 65 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 Johnson & Johnson Professionals, Inc. devices

FDA 510(k) Submission Details - K832062

510(k) Number K832062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1983
Decision Date August 31, 1983
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 127d · This submission: 65d
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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K832062.
CURAY-SUPPORT, CORE BUILD-UP MATERIAL
K832781 · Scientific Pharmaceuticals, Inc. · Oct 1983
DENTACOLOR LIGHT CURING CROWN & BRIDGE
K831215 · Kulzer, Inc. · Sep 1983
LIGHT CURING BONDING AGENT
K832061 · Johnson & Johnson Professionals, Inc. · Aug 1983
CERTAIN *DENTAL RESTORATIVE
K831559 · Johnson & Johnson Professionals, Inc. · Jun 1983
MICRODAPT DENTAL RESTORATIVE
K830380 · Johnson & Johnson Professionals, Inc. · Mar 1983
PRISMA-FINE
K830442 · Dentsply Intl. · Mar 1983