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: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT 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
• 4-259 ISO 14801 Third edition 2016-11-01
  Dentistry - Implants - Dynamic loading test for endosseous dental implants
• 4-270 ADA ANSI Technical Report No. 146-2018
  CAD/CAM Abutments in Dentistry
• 4-338 ISO 22683 First edition 2022-05
  Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems
• 8-226 ASTM F603-12 (Reapproved 2020)
  Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application

Guidance Document

• Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible