Cleared Traditional

K974282 - VITALESCENCE

K974282 is an FDA 510(k) clearance for VITALESCENCE, 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 76-day FDA review.

K974282 · Ultradent Products, Inc. · Dental device
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Jan 1998
Decision
76d
Days
Class 2
Risk

K974282 is an FDA 510(k) clearance for the VITALESCENCE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 29, 1998 after a review of 76 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 Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K974282

510(k) Number K974282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1997
Decision Date January 29, 1998
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
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 K974282.
DYRACT AP RESTORATIVE
K973235 · Dentsply Intl. · Feb 1998
PERMAFLO
K974413 · Ultradent Products, Inc. · Feb 1998
COMPOGLASS FLOW
K974577 · Ivoclar North America, Inc. · Jan 1998
KERR COMPOMER
K974105 · Sybron Dental Specialties, Inc. · Jan 1998
SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER
K973513 · Espe GmbH & Co. Kg. · Dec 1997
ALERT
K974131 · Jeneric/Pentron, Inc. · Dec 1997