Cleared Traditional

CAULK OPAQUER (K813357) - FDA 510(k) Clearance

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

K813357 · Dentsply Intl. · Dental device
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Jan 1982
Decision
41d
Days
Class 2
Risk

K813357 is an FDA 510(k) clearance for the CAULK OPAQUER. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentsply Intl. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1982 after a review of 41 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 Dentsply Intl. devices

Submission Details

510(k) Number K813357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1981
Decision Date January 07, 1982
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
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 194
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K813357.
PRISMA-FINE
K830442 · Dentsply Intl. · Mar 1983
GAMMA LIGHT CURING DENTAL RESTORATIVE
K823185 · Johnson & Johnson Professionals, Inc. · Nov 1982
AURAFILL* DENTAL RESTORATIVE
K822450 · Johnson & Johnson Professionals, Inc. · Sep 1982
ADAPTIC* C.F.S.
K812449 · Johnson & Johnson Professionals, Inc. · Sep 1981
ENHANCE DENTAL RESTORATIVE
K811443 · Johnson & Johnson Professionals, Inc. · Jun 1981
SILUX RESTORATIVE MATERIAL & ENAMEL BOND
K810595 · 3M Company · Mar 1981