Cleared Traditional

K910069 - SR-ISOSIT SPECTRA LINK SYSTEM

K910069 is the FDA 510(k) clearance for SR-ISOSIT SPECTRA LINK SYSTEM by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 418-day FDA review.

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
Combination Product No
PCCP Authorized No
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 282
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K910069.
BISCO UNIVERSAL BOND-3
K923842 · Bisco, Inc. · Sep 1992
DURAFILL BOND
K921701 · Heraeus Kulzer, Inc. · Jun 1992
SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM
K920424 · 3M Company · Mar 1992
PRISMA UNIVERSAL BOND(R) 3
K915830 · Dentsply Intl. · Mar 1992
ESPE(R) -SIL
K913965 · Espe GmbH (Us) · Dec 1991
IMPERVA DUAL
K913946 · Shofu Dental Corp. · Dec 1991