FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TECHFIT DISRP® System
K Number: K242263
·
Decision Dec 11, 2024
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
31
Applicant Total
4
Review Days
132
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Basic Information
- Device Name
- TECHFIT DISRP® System
- K Number
- K242263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4120
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Techfit Digital Surgery, Inc.
- Date Received
- August 1, 2024
- Decision Date
- December 11, 2024
- Product Code
- DZJ
- 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 |
|---|---|---|---|
| DZJ | Driver, Wire, And Bone Drill, Manual | FDA class 2 | Dental |
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