Cleared Traditional

K082463 - PROGENIX

K082463 is an FDA 510(k) clearance for PROGENIX, manufactured by Medtronic Sofamor Danek. The device is a Class 2 Dental device with product code NUN cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K082463 · Medtronic Sofamor Danek · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
75d
Days
Class 2
Risk

K082463 is an FDA 510(k) clearance for the PROGENIX. Classified as Bone Grafting Material, Human Source (product code NUN), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on November 10, 2008 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Sofamor Danek devices

FDA 510(k) Submission Details - K082463

510(k) Number K082463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2008
Decision Date November 10, 2008
Days to Decision 75 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 127d · This submission: 75d
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 13
Devices cleared under the same product code (NUN) and FDA review panel - the closest regulatory comparables to K082463.
REGENEROSS ALLOGRAFT PLUS MINERLIZED
K113645 · Biomet Interpore Cross · Jan 2012
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
K103699 · Exactech, Inc. · Aug 2011
DBX DEMINERALIZED BONE MATRIX PUTTY
K091217 · Musculoskeletal Transplant Foundation · Oct 2009
PROGENIX PLUS
K081950 · Medtronic Sofamor Danek, Inc. · Jul 2008
PROGENIX DBM PUTTY
K080462 · Medtronic Sofamor Danek · May 2008
INTERGRO ORAL
K070147 · Biomet 3i · May 2007