Cleared Traditional

K011839 - DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C

K011839 is an FDA 510(k) clearance for DOXADENT DENTAL COMPOSITE, manufactured by Doxa Certex AB. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K011839 · Doxa Certex AB · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
219d
Days
Class 2
Risk

K011839 is an FDA 510(k) clearance for the DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Doxa Certex AB (Washington, US). The FDA issued a Cleared decision on January 17, 2002 after a review of 219 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K011839

510(k) Number K011839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2001
Decision Date January 17, 2002
Days to Decision 219 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
91d slower than avg
Panel avg: 128d · This submission: 219d
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 932
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K011839.
HELIOMOLAR HB TRANSLUCENT SHADES
K013929 · Ivoclar Vivadent, Inc. · Feb 2002
EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804
K014144 · Afp Imaging Corp. · Feb 2002
POINT 4 MODIFIED
K013510 · Sybron Dental Specialties, Inc. · Jan 2002
MAGICFIL
K013571 · Dmg USA, Inc. · Jan 2002
REVOLUTION FORMULA 2
K013647 · Sybron Dental Specialties, Inc. · Jan 2002
POINT 4 TRANSLUCENT MODIFIED
K013529 · Sybron Dental Specialties, Inc. · Jan 2002
K011839 · DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C
Download PDF FDA Summary Doxa Certex AB