FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
S.I.N. Instrument Kits
K Number: K222005
·
Decision Sep 29, 2022
Classifications
1
FEI Numbers
266
Registration Numbers
266
Same Product Code
279
Applicant Total
12
Review Days
84
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Basic Information
- Device Name
- S.I.N. Instrument Kits
- K Number
- K222005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S.I.N. - Sistema DE Implante Nacional S.A.
- Date Received
- July 7, 2022
- Decision Date
- September 29, 2022
- Product Code
- KCT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | FDA class 2 | General Hospital |
Similar 510(k) Clearances
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Other Clearances by S.I.N. - Sistema DE Implante Nacional S.A.
| K Number | Device Name | ||
|---|---|---|---|
| K240609 | S.I.N. Dental Implant System | Jul 17, 2024 | Substantially Equivalent |
| K241378 | S.I.N. Instrument Kits | Jul 12, 2024 | Substantially Equivalent |
| K232821 | S.I.N. Dental Implant System | May 31, 2024 | Substantially Equivalent |
| K231127 | S.I.N. Dental Implant System | Dec 7, 2023 | Substantially Equivalent |
| K222231 | S.I.N. Dental Implant System | Oct 27, 2022 | Substantially Equivalent |
| K212404 | S.I.N. Instrument Kits | Nov 3, 2021 | Substantially Equivalent |
| K211921 | S.I.N. Dental Implant System | Oct 20, 2021 | Substantially Equivalent |
| K203725 | S.I.N. Dental Implant System | Jun 23, 2021 | Substantially Equivalent |
| K200992 | S.I.N. Dental Implant System | Nov 17, 2020 | Substantially Equivalent |
| K201688 | S.I.N. Instrument Kits | Oct 21, 2020 | Substantially Equivalent |