Cleared Traditional

SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN (K864708) - FDA 510(k) Clearance

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

K864708 · Ivoclar USA, Inc. · Dental device
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Feb 1987
Decision
85d
Days
Class 2
Risk

K864708 is an FDA 510(k) clearance for the SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Ivoclar USA, Inc. (Chicago, US). The FDA issued a Cleared decision on February 25, 1987 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Ivoclar USA, Inc. devices

Submission Details

510(k) Number K864708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1986
Decision Date February 25, 1987
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 79
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K864708.
NEW TRIAD TRANSHEET DENTURE BASE MATERIAL
K905702 · Dentsply Intl. · Apr 1991
LITELINE VLC SOFT RELINE
K895742 · Dentsply Intl. · Dec 1989
TRIAD ORTHODONTIC GEL
K882482 · Dentsply Intl. · Aug 1988
TRIAD IMPACT
K863324 · Dentsply Intl. · Sep 1986
DENTURE BASE RESIN
K834409 · Dentsply Intl. · Feb 1984
DENTURE RELINING, REPAIR/REBASING RESIN
K831647 · Dentsply Intl. · Jun 1983