FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TDS ABUTMENT
K Number: K081460
·
Decision Nov 21, 2008
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
6
Review Days
182
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Basic Information
- Device Name
- TDS ABUTMENT
- K Number
- K081460
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pou YU Biotechnology Co., Ltd.
- Date Received
- May 23, 2008
- Decision Date
- November 21, 2008
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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Other Clearances by Pou YU Biotechnology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K103339 | TDS ABUTMENT FOR FRIADENT XIVE | Mar 31, 2011 | Substantially Equivalent |
| K100356 | TDS PRECISION DENTAL BAR | Oct 5, 2010 | Substantially Equivalent |
| K091693 | TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARK | Jul 30, 2009 | Substantially Equivalent |
| K091392 | TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK | Jul 30, 2009 | Substantially Equivalent |
| K091026 | TDS ABUTMENT FOR NOBEL BIOCARE REPLACE | Jun 24, 2009 | Substantially Equivalent |