Cleared Traditional

ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT (K945300) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945300 · "O" Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
108d
Days
Class 2
Risk

K945300 is an FDA 510(k) clearance for the ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by "O" Co., Inc. (Albuquerque, US). The FDA issued a Cleared decision on February 16, 1995 after a review of 108 days - within the typical 510(k) review window.

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 "O" Co., Inc. devices

Submission Details

510(k) Number K945300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1994
Decision Date February 16, 1995
Days to Decision 108 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 127d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 303
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K945300.
TREFOIL System
K170135 · Nobel Biocare AB · May 2017
NobelZygoma 0°
K161598 · Nobel Biocare AB · Mar 2017
DENTSPLY PRECISION TORQUE SYSTEM
K964046 · Dentsply Intl. · Mar 1997
LORENZ SURGICAL THREADED DENTAL IMPLANT
K941619 · Biomet, Inc. · Sep 1994
LORENZ SURGICAL CYLINDER DENTAL IMPLANT
K941620 · Biomet, Inc. · Sep 1994
LORENZ SURGICAL FINNED DENTAL IMPLANT
K941621 · Biomet, Inc. · Sep 1994