FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
PRAMA White Implant Systems
K Number: K180365
·
Decision Jul 8, 2019
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
8
Review Days
511
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Basic Information
- Device Name
- PRAMA White Implant Systems
- K Number
- K180365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sweden & Martina S.P.A.
- Date Received
- February 12, 2018
- Decision Date
- July 8, 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 Sweden & Martina S.P.A.
| K Number | Device Name | ||
|---|---|---|---|
| K222640 | Sweden & Martina Surgical Trays | May 26, 2023 | Substantially Equivalent |
| K182084 | Sweden & Martina Surgical Tray (Model ZSHORTY-INT) | Nov 4, 2020 | Substantially Equivalent |
| K161989 | PREMIUM Implant Systems SHELTA Implant Systems | Feb 1, 2018 | Substantially Equivalent |
| K172560 | PREMIUM ONE Implant Systems | Dec 21, 2017 | Substantially Equivalent |
| K162028 | PREMIUM - SHELTA Prosthetic Components | Mar 24, 2017 | Substantially Equivalent |
| K162004 | PREMIUM Implant Systems SHELTA Implant Systems | Dec 5, 2016 | Substantially Equivalent |
| K142242 | PREMIUM, SHELTA Implant Systems | Feb 2, 2015 | Substantially Equivalent |