Cleared Traditional

K014144 - EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804

K014144 is an FDA 510(k) clearance for EXTORAL/TESCERA GLAZING RESIN, manufactured by Afp Imaging Corp.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K014144 · Afp Imaging Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
51d
Days
Class 2
Risk

K014144 is an FDA 510(k) clearance for the EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Afp Imaging Corp. (Elmsford, US). The FDA issued a Cleared decision on February 7, 2002 after a review of 51 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.

FDA 510(k) Submission Details - K014144

510(k) Number K014144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2001
Decision Date February 07, 2002
Days to Decision 51 days
Submission Type Traditional
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
77d faster than avg
Panel avg: 128d · This submission: 51d
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 934
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K014144.
VENUS UNIVERSAL LIGHT CURING COMPOSITE
K020131 · Heraeus Kulzer, Inc. · Feb 2002
PRIME-DENT HEMA DESENSITIZER
K013970 · Prime Dental Manufacturing, Inc. · Feb 2002
HELIOMOLAR HB TRANSLUCENT SHADES
K013929 · Ivoclar Vivadent, Inc. · Feb 2002
POINT 4 MODIFIED
K013510 · Sybron Dental Specialties, Inc. · Jan 2002
DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
K011839 · Doxa Certex AB · Jan 2002
MAGICFIL
K013571 · Dmg USA, Inc. · Jan 2002
K014144 · EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804
Download PDF FDA Summary Afp Imaging Corp.