Cleared Traditional

K945706 - BONE DRILL

K945706 is an FDA 510(k) clearance for BONE DRILL, manufactured by Osteo Implant Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K945706 · Osteo Implant Corp. · Dental device
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Jul 1995
Decision
235d
Days
Class 2
Risk

K945706 is an FDA 510(k) clearance for the BONE DRILL. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Osteo Implant Corp. (New Castle, US). The FDA issued a Cleared decision on July 14, 1995 after a review of 235 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 Osteo Implant Corp. devices

FDA 510(k) Submission Details - K945706

510(k) Number K945706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1994
Decision Date July 14, 1995
Days to Decision 235 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
108d slower than avg
Panel avg: 127d · This submission: 235d
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 1317
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K945706.
BRANEMARK SYSTEM BALL ATTACHMENT SYSTEM
K952676 · Nobelpharma USA, Inc. · Aug 1995
WIDE SCREWS TP-4K, PROS-G4, TOOLS G4 OR 17-4 SS
K952988 · Implant Center of the Palm Beaches · Jul 1995
WIDE STR-TP-4K, PROS STR, CLY-STR-TP 4
K952989 · Implant Center of the Palm Beaches · Jul 1995
KIS-II IMPLANT FIXTURES
K951606 · Implant Center of the Palm Beaches · Jul 1995
BIO-VENT IMPLANT
K950575 · Core-Vent Corp. · Jul 1995
BIO-VENT X IMPLANT
K950576 · Core-Vent Corp. · Jul 1995