Cleared Traditional

K921409 - ENAMEL AND PORCELAIN ETCH PRODUCT LINE

K921409 is an FDA 510(k) clearance for ENAMEL AND PORCELAIN ETCH PRODUCT LINE, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K921409 · Ultradent Products, Inc. · Dental device
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Sep 1992
Decision
169d
Days
Class 2
Risk

K921409 is an FDA 510(k) clearance for the ENAMEL AND PORCELAIN ETCH PRODUCT LINE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 9, 1992 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K921409

510(k) Number K921409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date September 09, 1992
Days to Decision 169 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
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K921409.
BISCO D/C RESINOMER
K924151 · Bisco, Inc. · Dec 1992
TRIAD INLAY COMPOSITE
K923236 · Dentsply Intl. · Sep 1992
COMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINE
K921407 · Ultradent Products, Inc. · Sep 1992
ULTRADENT PRODUCT PIT & FISSURE SEALANT PROD LINE
K921598 · Ultradent Products, Inc. · Sep 1992
ULTRADENT PRODUCT TOOTH SURFACE DRYING AGENT
K921602 · Ultradent Products, Inc. · Sep 1992
LITE FIL II A
K920892 · Shofu Dental Corp. · Sep 1992