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
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT Devices (DHT1B)
• Submission Type: PMA
• Regulation Number: 872.3960
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12
  Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• 8-405 ISO 5832-4 Third edition 2014-09-15
  Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
• 8-406 ISO 5832-11 Second edition 2014-09-15
  Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
• 8-465 ISO 5832-2 Fourth edition 2018-03
  Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
• 8-500 ISO 5832-12 Third edition 2019-02
  Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
• 8-585 ASTM F1377-21
  Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538)
• 8-587 ISO 5832-3 Fifth Edition 2021-11
  Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
• 8-594 ISO 5832-6 Third Edition 2022-03
  Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
• 8-595 ISO 5832-5 Fourth Edition 2022-03
  Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel

Third Party Review

Not Third Party Eligible