Cleared Traditional

K954690 - STRYKER ORAL MAX SYSTEM

K954690 is an FDA 510(k) clearance for STRYKER ORAL MAX SYSTEM, manufactured by Stryker Corp.. The device is a Class 2 Dental device with product code DZI cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K954690 · Stryker Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
314d
Days
Class 2
Risk

K954690 is an FDA 510(k) clearance for the STRYKER ORAL MAX SYSTEM. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on August 20, 1996 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - 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. Elevated predicate reliance profile. 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 Stryker Corp. devices

FDA 510(k) Submission Details - K954690

510(k) Number K954690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1995
Decision Date August 20, 1996
Days to Decision 314 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
187d slower than avg
Panel avg: 127d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZI Device Classification - Class 2, Special Controls

Product Code DZI Drill, Bone, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
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 - DZI Drill, Bone, Powered

All 44
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K954690.
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K871648 · Aspen Laboratories, Inc. · Jun 1987
ARTUS DRILL #6000
K803288 · Jedmed Instrument Co. · Jan 1981