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Product Classification

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Device

external mandibular fixator and/or distractor

Regulation Description

Bone plate.

Regulation Medical Specialty

Dental

Review Panel

Dental

Product Code

MQN

Submission Type

510(k)

Regulation Number

872.4760

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

ISO 5832-5:2005 Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
ISO 5832-1:2007 Implants for surgery -- Metallic materials -- Part 1: Wrought stainless steel
ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
ISO 5832-12:2007 Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy
ISO 5832-9:2007 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
ISO 5832-11:1994 Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
ISO 5832-6:1997 Implants for surgery -- Metallic materials -- Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
ISO 5832-4:1996 Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
ISO 5832-2:1999 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium

Third Party Review

Not Third Party Eligible

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