Product Classification

• Device: implant, endosseous, root-form
• Regulation Description: Endosseous dental implant.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: DZE
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.3640
• 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
• 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12
  Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• 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
• 8-195 ASTM F2024-10 (Reapproved 2016)
  Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
• 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
• 8-585 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
• 8-620 ISO 5832-11 Third edition 2024-03
  Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy

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