Cleared Traditional

K091217 - DBX DEMINERALIZED BONE MATRIX PUTTY

K091217 is an FDA 510(k) clearance for DBX DEMINERALIZED BONE MATRIX PUTTY, manufactured by Musculoskeletal Transplant Foundation. The device is a Class 2 Dental device with product code NUN cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K091217 · Musculoskeletal Transplant Foundation · Dental device
Download Printable Device Report (PDF)
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Oct 2009
Decision
158d
Days
Class 2
Risk

K091217 is an FDA 510(k) clearance for the DBX DEMINERALIZED BONE MATRIX PUTTY. Classified as Bone Grafting Material, Human Source (product code NUN), Class II - Special Controls.

Submitted by Musculoskeletal Transplant Foundation (Edison, US). The FDA issued a Cleared decision on October 2, 2009 after a review of 158 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Musculoskeletal Transplant Foundation devices

FDA 510(k) Submission Details - K091217

510(k) Number K091217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2009
Decision Date October 02, 2009
Days to Decision 158 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 127d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUN Device Classification - Class 2, Special Controls

Product Code NUN Bone Grafting Material, Human Source
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition 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, Implant Preparation/placement); Sinus Lifts; Cystic Defects; Craniofacial Augmentation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NUN Bone Grafting Material, Human Source

All 10
Devices cleared under the same product code (NUN) and FDA review panel - the closest regulatory comparables to K091217.
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
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