Cleared Traditional

K112279 - QUANTUM DENTAL IMPLANT SYSTEM

K112279 is an FDA 510(k) clearance for QUANTUM DENTAL IMPLANT SYSTEM, manufactured by Quantum Bioengineering, Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K112279 · Quantum Bioengineering, Ltd. · Dental device
Download Printable Device Report (PDF)
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May 2012
Decision
269d
Days
Class 2
Risk

K112279 is an FDA 510(k) clearance for the QUANTUM DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Quantum Bioengineering, Ltd. (San Diego, US). The FDA issued a Cleared decision on May 4, 2012 after a review of 269 days - an extended review 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: 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 Quantum Bioengineering, Ltd. devices

FDA 510(k) Submission Details - K112279

510(k) Number K112279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2011
Decision Date May 04, 2012
Days to Decision 269 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
142d slower than avg
Panel avg: 127d · This submission: 269d
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 869
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K112279.
ET II BIO-SA FIXTURE SYSTEM
K112532 · Hiossen, Inc. · Aug 2012
CMI IMPLANT IS II ACTIVE
K120503 · Neobiotech Co., Ltd. · Jun 2012
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
K121131 · Straumann USA · Jun 2012
CMI IMPLANT IS SYSTEM
K113554 · Neobiotech Co., Ltd. · Apr 2012
S-MINI IMPLANT SYSTEM
K112540 · Neobiotech Co., Ltd. · Feb 2012
HAPTITE COATING IMPLANT SYSTEM
K111364 · Dentis Co., Ltd. · Feb 2012