Cleared Traditional

K931539 - NORMED TITANIUM MINIPLATE SYSTEM

K931539 is an FDA 510(k) clearance for NORMED TITANIUM MINIPLATE SYSTEM, manufactured by Normed Medizin-Technik GmbH. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 463-day FDA review.

K931539 · Normed Medizin-Technik GmbH · Dental device
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Jul 1994
Decision
463d
Days
Class 2
Risk

K931539 is an FDA 510(k) clearance for the NORMED TITANIUM MINIPLATE SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Normed Medizin-Technik GmbH (Arlington, US). The FDA issued a Cleared decision on July 5, 1994 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Normed Medizin-Technik GmbH devices

FDA 510(k) Submission Details - K931539

510(k) Number K931539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1993
Decision Date July 05, 1994
Days to Decision 463 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
336d slower than avg
Panel avg: 127d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

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 205
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K931539.
MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST
K944560 · KLS-Martin L.P. · Oct 1994
MICRO OSTEOSYNTHESIS SYSTEM (1.0)
K944561 · KLS-Martin L.P. · Oct 1994
KLS-MARTIN MICRO OSTEOSYTHESIS SYSTEM(1.5MM)
K944565 · KLS-Martin L.P. · Oct 1994
AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS
K923705 · Aesculap, Inc. · Feb 1994
OSTEOMED M3 SYSTEM (SBF SYSTEM)
K924138 · Osteomed Corp. · Feb 1993
LORENZ 1.0 MM SYSTEM
K922741 · Walter Lorenz Surgical, Inc. · Dec 1992