Cleared Traditional

K991696 - STRYKER HERMES-READY TOTAL PERFORMANCE ...

K991696 is the FDA 510(k) clearance for STRYKER HERMES-READY TOTAL PERFORMANCE ... by Stryker Instruments. It is a Class 2 Dental device (product code DZI) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K991696 · Stryker Instruments · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
160d
Days
Class 2
Risk

K991696 is an FDA 510(k) clearance for the STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM. Classified as Drill, Bone, Powered (product code DZI), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on October 25, 1999 after a review of 160 days - an extended review cycle.

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. 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 Stryker Instruments devices

Submission Details

510(k) Number K991696 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1999
Decision Date October 25, 1999
Days to Decision 160 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
33d slower than avg
Panel avg: 127d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (DZI) and FDA review panel - the closest regulatory comparables to K991696.
MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
K060270 · Linvatec Corp. · Apr 2006
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
K032607 · Linvatec Corp. · Nov 2003
STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
K032117 · Stryker Instruments · Aug 2003
STRYKER ORAL MAX SYSTEM
K954690 · Stryker Corp. · Aug 1996
TMJ CANNULA SET
K871648 · Aspen Laboratories, Inc. · Jun 1987
ARTUS DRILL #6000
K803288 · Jedmed Instrument Co. · Jan 1981