Cleared Traditional

K080418 - REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST (FDA 510(k) Clearance)

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

K080418 · Regeneration Technologies, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
75d
Days
Class 2
Risk

K080418 is an FDA 510(k) clearance for the REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS S.... Classified as Bone Grafting Material, Human Source (product code NUN), Class II - Special Controls.

Submitted by Regeneration Technologies, Inc. (Alachua, US). The FDA issued a Cleared decision on April 30, 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 Regeneration Technologies, Inc. devices

Submission Details

510(k) Number K080418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2008
Decision Date April 30, 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.