FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHO EASY PIN
K Number: K110275
·
Decision Jun 3, 2011
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
51
Applicant Total
4
Review Days
123
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Basic Information
- Device Name
- ORTHO EASY PIN
- K Number
- K110275
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Forestadent Bernhard Forster GmbH
- Date Received
- January 31, 2011
- Decision Date
- June 3, 2011
- Product Code
- OAT
- 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 |
|---|---|---|---|
| OAT | Implant, Endosseous, Orthodontic | FDA class 2 | Dental |
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