FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇷 Türkiye
Mini Screws
K Number: K231502
·
Decision Sep 4, 2024
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
51
Applicant Total
3
Review Days
469
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Basic Information
- Device Name
- Mini Screws
- K Number
- K231502
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Proimtech Saglik Urunleri Anonim Sirketi
- Date Received
- May 24, 2023
- Decision Date
- September 4, 2024
- 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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