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
• Submission Type: 510(k)
• Regulation Number: 872.3630
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
• ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants
• AAMI/ANSI/ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
• ASTM F603-12 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