Cleared Traditional

K110337 - UNIVERSAL MAXILLARY MOLAR

K110337 is an FDA 510(k) clearance for UNIVERSAL MAXILLARY MOLAR, manufactured by Oco Biomedical. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 406-day FDA review.

K110337 · Oco Biomedical · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
406d
Days
Class 2
Risk

K110337 is an FDA 510(k) clearance for the UNIVERSAL MAXILLARY MOLAR. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Oco Biomedical (Albuquerque, US). The FDA issued a Cleared decision on March 16, 2012 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K110337

510(k) Number K110337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2011
Decision Date March 16, 2012
Days to Decision 406 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
278d slower than avg
Panel avg: 128d · This submission: 406d
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 1483
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K110337.
PALTOP DENTAL IMPLANT SYSTEM
K112795 · Paltop Advanced Dental Solutions, Ltd. · Apr 2012
AB DENTAL DEVICES IMPLANTS AND ACCESSORIES
K112440 · A.B. Dental Devices , Ltd. · Apr 2012
CMI IMPLANT IS SYSTEM
K113554 · Neobiotech Co., Ltd. · Apr 2012
KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10
K112758 · Kat Implants, LLC · Feb 2012
S-MINI IMPLANT SYSTEM
K112540 · Neobiotech Co., Ltd. · Feb 2012
HAPTITE COATING IMPLANT SYSTEM
K111364 · Dentis Co., Ltd. · Feb 2012
K110337 · UNIVERSAL MAXILLARY MOLAR
Download PDF FDA Summary Oco Biomedical