Cleared Traditional

K051188 - GRAFTON DBM

K051188 is an FDA 510(k) clearance for GRAFTON DBM, manufactured by Osteotech, Inc.. The device is a Class 2 Dental device with product code NUN cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K051188 · Osteotech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
238d
Days
Class 2
Risk

K051188 is an FDA 510(k) clearance for the GRAFTON DBM. Classified as Bone Grafting Material, Human Source (product code NUN), Class II - Special Controls.

Submitted by Osteotech, Inc. (Eatontown, US). The FDA issued a Cleared decision on January 3, 2006 after a review of 238 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 Osteotech, Inc. devices

FDA 510(k) Submission Details - K051188

510(k) Number K051188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2005
Decision Date January 03, 2006
Days to Decision 238 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
111d slower than avg
Panel avg: 127d · This submission: 238d
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 12
Devices cleared under the same product code (NUN) and FDA review panel - the closest regulatory comparables to K051188.
PROGENIX DBM PUTTY
K080462 · Medtronic Sofamor Danek · May 2008
ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY
K060332 · Isotis NV · Mar 2006
ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY
K060306 · Isotis NV · Mar 2006
GRAFTON PLUS DBM PASTE
K042707 · Osteotech, Inc. · Nov 2005
DYNAGRAFT II DENTAL
K043573 · Isotis Orthobiologics, Inc. · Jul 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
K040501 · Musculoskeletal Transplant Foundation · Apr 2005