Cleared Traditional

K873926 - STORZ CONTOURED ANATOMICAL PLATING INST...

K873926 is the FDA 510(k) clearance for STORZ CONTOURED ANATOMICAL PLATING INST... by Storz Instrument Co.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K873926 · Storz Instrument Co. · Dental device
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Feb 1988
Decision
147d
Days
Class 2
Risk

K873926 is an FDA 510(k) clearance for the STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Storz Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on February 19, 1988 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Storz Instrument Co. devices

Submission Details

510(k) Number K873926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1987
Decision Date February 19, 1988
Days to Decision 147 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 127d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 163
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K873926.
LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM
K910038 · Walter Lorenz Surgical, Inc. · Feb 1991
LUHR MICRO MESH
K901940 · Howmedica Corp. · Sep 1990
LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES
K901941 · Howmedica Corp. · Sep 1990
DUMBACH TITANIUM MESH IMPLANT SYSTEM
K862532 · Walter Lorenz Surgical, Inc. · Sep 1986
MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM
K862505 · Walter Lorenz Surgical, Inc. · Aug 1986
PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS
K862534 · Walter Lorenz Surgical, Inc. · Aug 1986