FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERGRO ORAL
K Number: K070147
·
Decision May 14, 2007
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
14
Applicant Total
12
Review Days
118
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INTERGRO ORAL
- K Number
- K070147
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet 3i
- Date Received
- January 16, 2007
- Decision Date
- May 14, 2007
- Product Code
- NUN
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NUN | Bone Grafting Material, Human Source | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NUN), ordered by most recent decision date.
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
FDA 510(k)
FDA Class 2
·Dental
REGENEROSS ALLOGRAFT PLUS MINERLIZED
FDA 510(k)
FDA Class 2
·Dental
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
FDA 510(k)
FDA Class 2
·Dental
DBX DEMINERALIZED BONE MATRIX PUTTY
FDA 510(k)
FDA Class 2
·Dental
PROGENIX
FDA 510(k)
FDA Class 2
·Dental
PROGENIX PLUS
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Biomet 3i
| K Number | Device Name | ||
|---|---|---|---|
| K183138 | Certain BellaTek Express and BellaTek Flex Abutments | Jul 2, 2019 | Substantially Equivalent |
| K173374 | TSV BellaTek Encode Healing Abutments | Dec 13, 2017 | Substantially Equivalent |
| K170013 | Eztetic BellaTek Encode Healing Abutments | Sep 21, 2017 | Substantially Equivalent |
| K150571 | 3i T3 Short Implants | Nov 20, 2015 | Substantially Equivalent |
| K133049 | 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS | Jan 8, 2014 | Substantially Equivalent |
| K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS | Jul 30, 2013 | Substantially Equivalent |
| K130310 | CERTAIN BELLATEK PROVISIONAL ABUTMENTS | Jun 21, 2013 | Substantially Equivalent |
| K122300 | T3 DENTAL IMPLANT | Jan 30, 2013 | Substantially Equivalent |
| K120776 | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION | Sep 11, 2012 | Substantially Equivalent |
| K112730 | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION | Jan 13, 2012 | Substantially Equivalent |