FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STICK FLOW
K Number: K031341
·
Decision Oct 29, 2003
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
9
Review Days
184
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Basic Information
- Device Name
- STICK FLOW
- K Number
- K031341
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stick Tech , Ltd.
- Date Received
- April 28, 2003
- Decision Date
- October 29, 2003
- 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 Stick Tech , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K051953 | EVERSTICK A&O | Mar 21, 2006 | Substantially Equivalent |
| K030820 | EVERSTICK POST | May 20, 2003 | Substantially Equivalent |
| K030072 | EVERSTICK PERIO | Apr 10, 2003 | Substantially Equivalent |
| K021126 | EVERSTICK ORTHO | May 13, 2002 | Substantially Equivalent |
| K011788 | EVERSTICK | Nov 5, 2001 | Substantially Equivalent |
| K011799 | EVERSTICKNET | Nov 5, 2001 | Substantially Equivalent |
| K003334 | STICK NET | Jan 8, 2001 | Substantially Equivalent |
| K003333 | STICK | Jan 4, 2001 | Substantially Equivalent |