Product Classification

• Device: bone grafting material, synthetic
• Regulation Description: Bone grafting material.
• Definition: A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: LYC
• 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: 872.3930
• 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 Standard

• 4-332 ADA ANSI Standard No. 206-2024
  Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File

Guidance Document

• Dental Bone Grafting Material Devices - Class II Special Controls Guidance Document - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible