FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
K Number: K180184
·
Decision Nov 16, 2018
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
4
Review Days
297
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Basic Information
- Device Name
- Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
- K Number
- K180184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentalpoint AG
- Date Received
- January 23, 2018
- Decision Date
- November 16, 2018
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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