FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇷 Türkiye
GBR System
K Number: K233419
·
Decision Jan 3, 2025
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
79
Applicant Total
3
Review Days
451
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Basic Information
- Device Name
- GBR System
- K Number
- K233419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4880
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Proimtech Saglik Urunleri Anonim Sirketi
- Date Received
- October 10, 2023
- Decision Date
- January 3, 2025
- Product Code
- DZL
- 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 |
|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | FDA class 2 | Dental |
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