Regenafil, Regenaform, Alriva DBM Paste, Sltiva DM with Cortical Cancellous Ships, Bioset, Sioset Ic, Rti Allograft Past
FDA 510(k) K080418 · Regeneration Technologies, Inc.
Submission
- Device name
- Regenafil, Regenaform, Alriva DBM Paste, Sltiva DM with Cortical Cancellous Ships, Bioset, Sioset Ic, Rti Allograft Past
- Applicant
- Regeneration Technologies, Inc.
Alachua, FL, US - Received
- February 15, 2008
- Decision date
- April 30, 2008
- 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 Regenafil, Regenaform, Alriva DBM Paste, Sltiva DM with Cortical Cancellous Ships, Bioset, Sioset Ic, Rti Allograft Past cleared by the FDA?
Regenafil, Regenaform, Alriva DBM Paste, Sltiva DM with Cortical Cancellous Ships, Bioset, Sioset Ic, Rti Allograft Past (K080418) received a 510(k) decision of Substantially Equivalent on April 30, 2008, 75 days after the submission was received.
What is the product code of K080418?
The FDA product code is NUN – Bone Grafting Material, Human Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.