Cleared Traditional

K042707 - GRAFTON PLUS DBM PASTE

K042707 is an FDA 510(k) clearance for GRAFTON PLUS DBM PASTE, 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 426-day FDA review.

K042707 · Osteotech, Inc. · Dental device
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Nov 2005
Decision
426d
Days
Class 2
Risk

K042707 is an FDA 510(k) clearance for the GRAFTON PLUS DBM PASTE. 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 November 30, 2005 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Osteotech, Inc. devices

FDA 510(k) Submission Details - K042707

510(k) Number K042707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2004
Decision Date November 30, 2005
Days to Decision 426 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
299d slower than avg
Panel avg: 127d · This submission: 426d
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 K042707.
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 DBM
K051188 · Osteotech, Inc. · Jan 2006
DYNAGRAFT II DENTAL
K043573 · Isotis Orthobiologics, Inc. · Jul 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX
K040501 · Musculoskeletal Transplant Foundation · Apr 2005