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Product Classification

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Device

lock, wire, and ligature, intraoral

Regulation Description

Intraoral ligature and wire lock.

Regulation Medical Specialty

Dental

Review Panel

Dental

Product Code

DYX

Submission Type

510(k)

Regulation Number

872.4600

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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