FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
PREMIUM Implant Systems SHELTA Implant Systems
K Number: K162004
·
Decision Dec 5, 2016
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
8
Review Days
138
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Basic Information
- Device Name
- PREMIUM Implant Systems SHELTA Implant Systems
- K Number
- K162004
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sweden & Martina S.P.A.
- Date Received
- July 20, 2016
- Decision Date
- December 5, 2016
- 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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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 |
| K180365 | PRAMA White Implant Systems | Jul 8, 2019 | 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 |
| K142242 | PREMIUM, SHELTA Implant Systems | Feb 2, 2015 | Substantially Equivalent |