FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BoneTrust Implant System
K Number: K182313
·
Decision Mar 11, 2019
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
2
Review Days
196
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Basic Information
- Device Name
- BoneTrust Implant System
- K Number
- K182313
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Instinct Deutschland GmbH
- Date Received
- August 27, 2018
- Decision Date
- March 11, 2019
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by Medical Instinct Deutschland GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K200573 | BoneTrust Mini Implant System | May 14, 2021 | Substantially Equivalent |