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Device
bone grafting material, animal source
Regulation Description
Bone grafting material.
Definition
A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.
Regulation Medical Specialty
Dental
Review Panel
Dental
Product Code
NPM
Premarket Review
Division of Dental and ENT Devices
(DHT1B)
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
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