Product Classification

• Device: abutment, implant, dental, endosseous
• Regulation Description: Endosseous dental implant abutment.
• Definition: To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: NHA
• Premarket Review: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Dental Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.3630
• Device Class: 2
• 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

• 2-170 ISO 10993-14 First edition 2001-11-15
  Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
• 4-195 ISO 14801 Second edition 2007-11-15
  Dentistry - Implants-Dynamic fatigue test for endosseous dental implants
• 4-259 ISO 14801 Third edition 2016-11-01
  Dentistry - Implants - Dynamic loading test for endosseous dental implants
• 4-270 ADA Technical Report No. 146-2018
  CAD/CAM Abutments in Dentistry
• 8-226 ASTM F603-12 (Reapproved 2020)
  Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

Third Party Review

Not Third Party Eligible