FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RN SYNOCTA TEMPORARY MESO ABUTMENT
K Number: K051717
·
Decision Jul 7, 2005
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
2
Review Days
10
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Basic Information
- Device Name
- RN SYNOCTA TEMPORARY MESO ABUTMENT
- K Number
- K051717
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Institut Straumann SA
- Date Received
- June 27, 2005
- Decision Date
- July 7, 2005
- 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 Institut Straumann SA
| K Number | Device Name | ||
|---|---|---|---|
| K003552 | ITI DENTAL IMPLANT SYSTEM | Aug 17, 2001 | Substantially Equivalent |