Cleared Traditional

K901940 - LUHR MICRO MESH

K901940 is the FDA 510(k) clearance for LUHR MICRO MESH by Howmedica Corp.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K901940 · Howmedica Corp. · Dental device
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Sep 1990
Decision
129d
Days
Class 2
Risk

K901940 is an FDA 510(k) clearance for the LUHR MICRO MESH. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on September 6, 1990 after a review of 129 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 Howmedica Corp. devices

Submission Details

510(k) Number K901940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1990
Decision Date September 06, 1990
Days to Decision 129 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
2d slower than avg
Panel avg: 127d · This submission: 129d
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 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K901940.
AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS
K923705 · Aesculap, Inc. · Feb 1994
LORENZ 1.0 MM SYSTEM
K922741 · Walter Lorenz Surgical, Inc. · Dec 1992
LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM
K910038 · Walter Lorenz Surgical, Inc. · Feb 1991
LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES
K901941 · Howmedica Corp. · Sep 1990
STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT
K873926 · Storz Instrument Co. · Feb 1988
DUMBACH TITANIUM MESH IMPLANT SYSTEM
K862532 · Walter Lorenz Surgical, Inc. · Sep 1986