Cleared Traditional

K010343 - BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316

K010343 is an FDA 510(k) clearance for BMR DENTAL IMPLANT SYSTEM, manufactured by Buck Medical Research. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K010343 · Buck Medical Research · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
9d
Days
Class 2
Risk

K010343 is an FDA 510(k) clearance for the BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Buck Medical Research (Dallas, US). The FDA issued a Cleared decision on February 14, 2001 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Buck Medical Research devices

FDA 510(k) Submission Details - K010343

510(k) Number K010343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2001
Decision Date February 14, 2001
Days to Decision 9 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 127d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1172
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K010343.
ITI DENTAL IMPLANT SYSTEM
K010291 · Straumann USA · May 2001
THE MAESTRO SYSTEM
K010458 · BioHorizons Implant Systems, Inc. · May 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · Institut Straumann AG · Mar 2001
ACE SDS 3.75MM SCREW DENTAL IMPLANT
K002075 · Ace Surgical Supply Co., Inc. · Feb 2001
OCO DENTAL IMPLANT
K010142 · "O" Co., Inc. · Feb 2001
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
K003226 · Lifecore Biomedical, Inc. · Jan 2001