DBX Demineralized Bone Matrix Putty

FDA 510(k) K091217 · Musculoskeletal Transplant Foundation

Substantially Equivalent

510(k) numberK091217

Submission

Device name
DBX Demineralized Bone Matrix Putty
Applicant
Musculoskeletal Transplant Foundation
Edison, NJ, US
Received
April 27, 2009
Decision date
October 2, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUN – Bone Grafting Material, Human Source
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3930
Specialty
Dental
Implant
Yes

INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS. THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE BONE, INLCUDING PERIODENTA/INFRABONY DEFECTS; ALVEOLAR RIDGE AUGMENTATION (SINUSOTOMY, OSTEOTOMY, CYSTECTOMY); DENTAL EXTRACTION SITES (RIDGE MAINTENANCE…

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K070147Intergro OralNUN · Traditional Biomet 3i05/14/2007SE
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Questions and answers

When was DBX Demineralized Bone Matrix Putty cleared by the FDA?

DBX Demineralized Bone Matrix Putty (K091217) received a 510(k) decision of Substantially Equivalent on October 2, 2009, 158 days after the submission was received.

What is the product code of K091217?

The FDA product code is NUN – Bone Grafting Material, Human Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.