Cleared Traditional

K130235 - SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY (FDA 510(k) Clearance)

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

K130235 · Hans Biomed Corp. · Dental device
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Jan 2014
Decision
345d
Days
Class 2
Risk

K130235 is an FDA 510(k) clearance for the SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY. Classified as Bone Grafting Material, Human Source (product code NUN), Class II - Special Controls.

Submitted by Hans Biomed Corp. (Chevy Chase, US). The FDA issued a Cleared decision on January 10, 2014 after a review of 345 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K130235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2013
Decision Date January 10, 2014
Days to Decision 345 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
218d slower than avg
Panel avg: 127d · This submission: 345d
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.