Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty
FDA 510(k) K130235 · Hans Biomed Corp.
Submission
- Device name
- Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty
- Applicant
- Hans Biomed Corp.
Chevy Chase, MD, US - Received
- January 30, 2013
- Decision date
- January 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUN – Bone Grafting Material, Human Source
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3930
- Specialty
- Dental
- Implant
- Yes
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…
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Questions and answers
When was Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty cleared by the FDA?
Surfuse II Gel, Surfuse II Putty, Exfuse II Gel, Exfuse II Putty (K130235) received a 510(k) decision of Substantially Equivalent on January 10, 2014, 345 days after the submission was received.
What is the product code of K130235?
The FDA product code is NUN – Bone Grafting Material, Human Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.