Bone Grafting Material, For Dental Bone Repair

Device Code: 1310

Product Code(s): LPK

Definition: Tricalcium Phosphate Bone Grafting Material

Device Classification Information

• Device Type ID: 1310
• Device Name: Bone Grafting Material, For Dental Bone Repair
• Regulation Description: Bone Grafting Material.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Dental Devices Branch (DEDB)
• Submission Type: 510(k)
• CFR Regulation Number: 872.3930 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: LPK
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 4-212 ISO 7405 Second Edition 2008-12-15
  Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]

Total Product Life Cycle

• Device Type ID: 1310
• Device: Bone Grafting Material, For Dental Bone Repair
• Product Code: LPK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Bone Grafting Material.
• CFR Regulation Number: 872.3930 [🔎]

Device Problems
Adverse Event Without Identified Device Or Use Problem	2
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:51:46