Cleared Traditional

K013970 - PRIME-DENT HEMA DESENSITIZER

K013970 is an FDA 510(k) clearance for PRIME-DENT HEMA DESENSITIZER, 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 78-day FDA review.

K013970 · Prime Dental Manufacturing, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
78d
Days
Class 2
Risk

K013970 is an FDA 510(k) clearance for the PRIME-DENT HEMA DESENSITIZER. 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 February 19, 2002 after a review of 78 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 - K013970

510(k) Number K013970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2001
Decision Date February 19, 2002
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
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 K013970.
UNIFIL FLOW
K020342 · GC America, Inc. · Mar 2002
REBILDA SC
K014111 · Voco GmbH · Mar 2002
VENUS UNIVERSAL LIGHT CURING COMPOSITE
K020131 · Heraeus Kulzer, Inc. · Feb 2002
HELIOMOLAR HB TRANSLUCENT SHADES
K013929 · Ivoclar Vivadent, Inc. · Feb 2002
POINT 4 MODIFIED
K013510 · Sybron Dental Specialties, Inc. · Jan 2002
MAGICFIL
K013571 · Dmg USA, Inc. · Jan 2002