Cleared Traditional

ADAPTIC* C.F.S. (K812449) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812449 · Johnson & Johnson Professionals, Inc. · Dental device

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Sep 1981

Decision

28d

Days

Class 2

Risk

K812449 is an FDA 510(k) clearance for the ADAPTIC* C.F.S.. 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 September 25, 1981 after a review of 28 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

Submission Details

510(k) Number	K812449 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 28, 1981
Decision Date	September 25, 1981
Days to Decision	28 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

99d faster than avg

Panel avg: 127d · This submission: 28d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 208

Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K812449.

GAMMA LIGHT CURING DENTAL RESTORATIVE

K823185 · Johnson & Johnson Professionals, Inc. · Nov 1982

AURAFILL* DENTAL RESTORATIVE

K822450 · Johnson & Johnson Professionals, Inc. · Sep 1982

CAULK OPAQUER

K813357 · Dentsply Intl. · Jan 1982

ENHANCE DENTAL RESTORATIVE

K811443 · Johnson & Johnson Professionals, Inc. · Jun 1981

SILUX RESTORATIVE MATERIAL & ENAMEL BOND

K810595 · 3M Company · Mar 1981

ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE

K802975 · Dentsply Intl. · Jan 1981

Related FDA 510(k) Regulatory Insights

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

Manufacturer of K812449

Johnson & Johnson Professionals, Inc.

Raynham, MA · US

Regulatory profile

206 submissions 184 cleared

89% clearance rate · Active in Dental

Data Intelligence Layer

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 . Updated monthly.

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