Intergro Oral
FDA 510(k) K070147 · Biomet 3i
510(k) numberK070147
Submission
- Device name
- Intergro Oral
- Applicant
- Biomet 3i
Palm Beach Gardens, FL, US - Received
- January 16, 2007
- Decision date
- May 14, 2007
- 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 Intergro Oral cleared by the FDA?
Intergro Oral (K070147) received a 510(k) decision of Substantially Equivalent on May 14, 2007, 118 days after the submission was received.
What is the product code of K070147?
The FDA product code is NUN – Bone Grafting Material, Human Source, a Class II (moderate risk) device regulated under 21 CFR 872.3930.