Cleared Traditional

SR-ISOSIT SPECTRA LINK SYSTEM (K910069) - FDA 510(k) Clearance

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

K910069 · Ivoclar North America, Inc. · Dental device
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Mar 1992
Decision
418d
Days
Class 2
Risk

K910069 is an FDA 510(k) clearance for the SR-ISOSIT SPECTRA LINK SYSTEM. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on March 2, 1992 after a review of 418 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Ivoclar North America, Inc. devices

Submission Details

510(k) Number K910069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1991
Decision Date March 02, 1992
Days to Decision 418 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
291d slower than avg
Panel avg: 127d · This submission: 418d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 83
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K910069.
NEW DENTINE ADHESIVE
K931812 · Dentsply Intl. · Jul 1993
NEW DENTIN PRIMER
K930504 · Dentsply Intl. · May 1993
SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM
K920424 · 3M Company · Mar 1992
PRISMA UNIVERSAL BOND(R) 3
K915830 · Dentsply Intl. · Mar 1992
DENTIN PRIMER
K891455 · Dentsply Intl. · May 1989
TEMPORARY DISCLOSING SOLUTION
K874074 · Dentsply Intl. · Dec 1987