Cleared Traditional

K001108 - PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL

K001108 is an FDA 510(k) clearance for PRIME-DENT VISIBLE LIGHT CURE COMPOSITE..., manufactured by Prime Dental Manufacturing, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K001108 · Prime Dental Manufacturing, Inc. · Dental device
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May 2000
Decision
55d
Days
Class 2
Risk

K001108 is an FDA 510(k) clearance for the PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Prime Dental Manufacturing, Inc. (Chicago, US). The FDA issued a Cleared decision on May 30, 2000 after a review of 55 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 Prime Dental Manufacturing, Inc. devices

FDA 510(k) Submission Details - K001108

510(k) Number K001108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2000
Decision Date May 30, 2000
Days to Decision 55 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
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 711
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K001108.
SCULPTURE FLOW
K001623 · Jeneric/Pentron, Inc. · Jul 2000
GRADIA
K001518 · GC America, Inc. · Jul 2000
SIGNUM
K001360 · J.F. Jelenko & Co., Inc. · Jun 2000
BELLEGLASS HP ENAMEL
K000530 · Sybron Dental Specialties, Inc. · May 2000
EZ CONNECT RESIN
K000357 · Kerr Dental Materials Center · Apr 2000
BELLEGLASS HP TRANSLUCENT DENTIN
K000436 · Sybron Dental Specialties, Inc. · Mar 2000