Cleared Traditional

K974160 - BRUXTRAK MATERIAL

K974160 is an FDA 510(k) clearance for BRUXTRAK MATERIAL, manufactured by Bruxcare, LLC. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K974160 · Bruxcare, LLC · Dental device
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Mar 1998
Decision
126d
Days
Class 2
Risk

K974160 is an FDA 510(k) clearance for the BRUXTRAK MATERIAL. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Bruxcare, LLC (Houston, US). The FDA issued a Cleared decision on March 11, 1998 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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.

View all Bruxcare, LLC devices

FDA 510(k) Submission Details - K974160

510(k) Number K974160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1997
Decision Date March 11, 1998
Days to Decision 126 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 127d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 219
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K974160.
KERR HARD DENTURE RELINE MATERIAL
K981448 · Sybron Dental Specialties, Inc. · Jun 1998
PERMAFIX CHAIRSIDE SOFT DENTURE RELINING (7010) (7011-13) (7014-15)
K980616 · Kohler Medizintechnik GmbH & Co. KG · Apr 1998
CSR
K974865 · Parkell, Inc. · Mar 1998
JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METR
K974727 · J.B.C and Co. · Feb 1998
MASKY
K973542 · Pressing DI Monticelli Rag. Stefano · Feb 1998
UFI GEL C
K974772 · Voco GmbH · Feb 1998