FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Stela Capsule System
K Number: K222583
·
Decision Oct 28, 2022
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
6
Review Days
63
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Basic Information
- Device Name
- Stela Capsule System
- K Number
- K222583
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sdi Limited
- Date Received
- August 26, 2022
- Decision Date
- October 28, 2022
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Sdi Limited
| K Number | Device Name | ||
|---|---|---|---|
| K222581 | Stela Automix System | Oct 28, 2022 | Substantially Equivalent |
| K214118 | Riva Cem Automix | Aug 30, 2022 | Substantially Equivalent |
| K191656 | Zipbond | Dec 2, 2019 | Substantially Equivalent |
| K172047 | Riva Star | Apr 11, 2018 | Substantially Equivalent |
| K102984 | AURA | Dec 8, 2010 | Substantially Equivalent |