Product Classification

• Device: mandibular condyle prosthesis
• Regulation Description: Mandibular condyle prosthesis.
• Definition: Pma to be filed by 3/30/99 (63 fr 71746 (12/30/98)).
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: MPL
• Submission Type: PMA
• Regulation Number: 872.3960
• Device Class: 3
• 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 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 5832-11:1994 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
• ASTM F1377-08 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

Third Party Review

Not Third Party Eligible