Cleared Abbreviated

K002086 - PRIMAFLOW

K002086 is an FDA 510(k) clearance for PRIMAFLOW, manufactured by Dmg USA, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 38-day FDA review.

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

FDA 510(k) Submission Details - K002086

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 127d · This submission: 38d
Pathway characteristics
Standards-based clearance path.

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 684
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K002086.
RENEW LS-2
K003361 · Bisco, Inc. · Nov 2000
RENEW LS-1
K003317 · Bisco, Inc. · Nov 2000
IMPROVED TRY-IN GEL
K001899 · Sybron Dental Specialties, Inc. · Aug 2000
SCULPTURE FLOW
K001623 · Jeneric/Pentron, Inc. · Jul 2000
GRADIA
K001518 · GC America, Inc. · Jul 2000
SIGNUM
K001360 · J.F. Jelenko & Co., Inc. · Jun 2000