FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRO-V
K Number: K073263
·
Decision Feb 14, 2008
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
88
Review Days
86
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Basic Information
- Device Name
- PRO-V
- K Number
- K073263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bisco, Inc.
- Date Received
- November 20, 2007
- Decision Date
- February 14, 2008
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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