Cleared Traditional

K922569 - TETRIC LIGHT-CURING COMPOSITE

K922569 is the FDA 510(k) clearance for TETRIC LIGHT-CURING COMPOSITE by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K922569 · Ivoclar North America, Inc. · Dental device
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Jul 1992
Decision
44d
Days
Class 2
Risk

K922569 is an FDA 510(k) clearance for the TETRIC LIGHT-CURING COMPOSITE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on July 15, 1992 after a review of 44 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 Ivoclar North America, Inc. devices

Submission Details

510(k) Number K922569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1992
Decision Date July 15, 1992
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 127d · This submission: 44d
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 577
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K922569.
LITE FILL II P
K920893 · Shofu Dental Corp. · Sep 1992
COMPOSITE RESIN CORE PASTE MATERIAL
K921174 · Centrix, Inc. · Sep 1992
PULPDENT HARD CORE
K922755 · Pulpdent Corp. · Aug 1992
BISCO CORE PASTE
K921439 · Bisco, Inc. · May 1992
10% PHOSPHORIC ACID ETCHING GEL
K920483 · Pulpdent Corp. · Apr 1992
PUPLDENT ETCH N PREP
K920485 · Pulpdent Corp. · Apr 1992