FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENUS DIAMOND FLOW
K Number: K091635
·
Decision Sep 3, 2009
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
11
Review Days
91
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Basic Information
- Device Name
- VENUS DIAMOND FLOW
- K Number
- K091635
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Heraeus Kulzer, LLC
- Date Received
- June 4, 2009
- Decision Date
- September 3, 2009
- 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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|---|---|---|---|
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| K113574 | FLEXITIME MONOPHASE PRO SCAN | Jul 13, 2012 | Substantially Equivalent |
| K112501 | VENUS PEARL PLT REFILL A1 | Dec 14, 2011 | Substantially Equivalent |
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| K110037 | PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID | Apr 29, 2011 | Substantially Equivalent |
| K102770 | FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW | Dec 21, 2010 | Substantially Equivalent |
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| K093575 | GLUMA DESENSITIZER POWER GEL | Mar 5, 2010 | Substantially Equivalent |