Cleared Abbreviated

PRIMAFLOW (K002086) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K002086 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
38d
Days
Class 2
Risk

K002086 is an FDA 510(k) clearance for the PRIMAFLOW. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on August 17, 2000 after a review of 38 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dmg USA, Inc. devices

Submission Details

510(k) Number K002086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2000
Decision Date August 17, 2000
Days to Decision 38 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 127d · This submission: 38d
Pathway characteristics
Standards-based clearance path.

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 332
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K002086.
3M ESPE HAUR
K010781 · 3M Company · Apr 2001
TETRIC CERAM HB
K010250 · Ivoclar North America, Inc. · Feb 2001
IMPROVED TRY-IN GEL
K001899 · Sybron Dental Specialties, Inc. · Aug 2000
GRADIA
K001518 · GC America, Inc. · Jul 2000
BELLEGLASS HP ENAMEL
K000530 · Sybron Dental Specialties, Inc. · May 2000
BELLEGLASS HP TRANSLUCENT DENTIN
K000436 · Sybron Dental Specialties, Inc. · Mar 2000