FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Fiber Disks and Blocks (TRINIA)
K Number: K143524
·
Decision Jun 2, 2015
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
5
Review Days
172
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Basic Information
- Device Name
- Fiber Disks and Blocks (TRINIA)
- K Number
- K143524
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bicon, LLC
- Date Received
- December 12, 2014
- Decision Date
- June 2, 2015
- 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 | ||
|---|---|---|---|
| K133608 | TRINIA | Mar 14, 2014 | 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 |