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# Dental Bone Graft Animal Study Guide
- URL: https://www.fdaweb.com/dental-bone-graft-animal-study-guide/
- Published: 2024-03-28T12:00:00.000Z
- Updated: 2026-09-14T14:26:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156651

FDA has published a draft guidance, *Animal Studies for Dental Bone Grafting Material Devices—Premarket Notification (510(k)) Submissions*, with recommendations for animal studies that may assist manufacturers in complying with some special controls for dental bone grafting material devices. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/animal-studies-dental-bone-grafting-material-devices-premarket-notification-510k-submissions?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the device is a material that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

When finalized, the guidance is to:

- provide recommendations for animal studies that may assist manufacturers in complying with some special controls for dental bone grafting material devices;
- provide recommendations for manufacturers who choose to combine an animal study with the biocompatibility evaluation of implantation;
- augment the recommendations in the Class II Special Controls guidance *Dental Bone Grafting Material Devices*; and
- promote consistency and facilitate efficient review of submissions for dental bone grafting material devices.

FDA will receive comments on the draft by 5/28.