Cleared Traditional

RESTORE* (K851929) - FDA 510(k) Clearance

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

K851929 · Johnson & Johnson Professionals, Inc. · Dental device
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Jul 1985
Decision
90d
Days
Class 2
Risk

K851929 is an FDA 510(k) clearance for the RESTORE*. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (East Windsor, US). The FDA issued a Cleared decision on July 31, 1985 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K851929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1985
Decision Date July 31, 1985
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K851929.
SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE
K861899 · 3M Company · Jun 1986
P-50 LIGHT CURED RESIN BONDED CERAMIC
K861740 · 3M Company · May 1986
DENTAL CEMENT
K853431 · Dentsply Intl. · Oct 1985
BIOGLOSS
K852659 · Dentsply Intl. · Jul 1985
ETEN-GEL
K852658 · Dentsply Intl. · Jul 1985
PHOTO CURING LIGHT
K852151 · Dentsply Intl. · Jul 1985