FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRINIA
K Number: K133608
·
Decision Mar 14, 2014
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
5
Review Days
109
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Basic Information
- Device Name
- TRINIA
- K Number
- K133608
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bicon, LLC
- Date Received
- November 25, 2013
- Decision Date
- March 14, 2014
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Bicon, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K143524 | Fiber Disks and Blocks (TRINIA) | Jun 2, 2015 | Substantially Equivalent |
| K101849 | BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT | Oct 1, 2010 | Substantially Equivalent |
| K092035 | BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION | Oct 15, 2009 | Substantially Equivalent |
| K073368 | 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT | Oct 10, 2008 | Substantially Equivalent |