Cleared Traditional

K082463 - PROGENIX (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082463 · Medtronic Sofamor Danek · Dental device
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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

Submission Details

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
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.

Device Classification

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.