Product Classification

• Device: blade-form endosseous dental implant
• Regulation Description: Endosseous dental implant.
• Definition: Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: NRQ
• 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: 872.3640
• 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

• 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

Third Party Review

Not Third Party Eligible