Cleared Traditional

K946129 - IMPLANT BODY DEPTH GAUGE/TRYIN

K946129 is an FDA 510(k) clearance for IMPLANT BODY DEPTH GAUGE/TRYIN, manufactured by "O" Co., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K946129 · "O" Co., Inc. · Dental device
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Mar 1995
Decision
75d
Days
Class 2
Risk

K946129 is an FDA 510(k) clearance for the IMPLANT BODY DEPTH GAUGE/TRYIN. 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 March 1, 1995 after a review of 75 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 "O" Co., Inc. devices

FDA 510(k) Submission Details - K946129

510(k) Number K946129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1994
Decision Date March 01, 1995
Days to Decision 75 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
52d faster than avg
Panel avg: 127d · This submission: 75d
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 868
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K946129.
BRANEMARK SYSTEM 3.3MM FIXTURE
K944683 · Nobelpharma USA, Inc. · Mar 1995
KIS-II IMPLANT FIXTURES
K943971 · Implant Center of the Palm Beaches · Mar 1995
KIS-II NON-ANGULATED ABUTMENTS
K943984 · Implant Center of the Palm Beaches · Mar 1995
RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM
K944069 · Lifecore Biomedical, Inc. · Feb 1995
BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM
K944964 · Nobelpharma USA, Inc. · Feb 1995
BRANEMARK SYSTEM 17 ANGULATED ABUTMENT
K944962 · Nobelpharma USA, Inc. · Feb 1995