Cleared Traditional

K951065 - SURGICAL INSTRUMENT MOTOTRS AND ACCESSO...

K951065 is an FDA 510(k) clearance for SURGICAL INSTRUMENT MOTOTRS AND ACCESSO..., manufactured by Steri-Oss, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K951065 · Steri-Oss, Inc. · Dental device
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Jun 1995
Decision
92d
Days
Class 2
Risk

K951065 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT MOTOTRS AND ACCESSORIES/ATTACHMENTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Steri-Oss, Inc. (Yorba Linda, US). The FDA issued a Cleared decision on June 8, 1995 after a review of 92 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 Steri-Oss, Inc. devices

FDA 510(k) Submission Details - K951065

510(k) Number K951065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1995
Decision Date June 08, 1995
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 127d · This submission: 92d
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 698
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K951065.
STERI-OSS SELF TAPING IMPLANT
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K952448 · Nobelpharma USA, Inc. · Jun 1995
OSTEOTOMES
K952193 · Steri-Oss, Inc. · Jun 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950446 · Steri-Oss, Inc. · May 1995
BONE CUTTING INSTRUMENT AND ACCESSORIES
K950936 · Steri-Oss, Inc. · Apr 1995