FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-SCREEN
K Number: K082668
·
Decision Jan 23, 2009
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
11
Applicant Total
7
Review Days
133
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Basic Information
- Device Name
- BIO-SCREEN
- K Number
- K082668
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6350
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Addent, Inc.
- Date Received
- September 12, 2008
- Decision Date
- January 23, 2009
- Product Code
- NXV
- 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 |
|---|---|---|---|
| NXV | Diagnostic Light, Soft Tissue Detector | FDA class 2 | Dental |
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Other Clearances by Addent, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K182017 | Compex HD | Apr 29, 2019 | Substantially Equivalent |
| K121282 | MICROLUX/DL MICROLUX/BLU BIO/SCREEN | Jul 24, 2012 | Substantially Equivalent |
| K072309 | MICROLUX/BLU | Nov 19, 2007 | Substantially Equivalent |
| K062961 | MICROLUX TRANSILLUMINATOR | Feb 8, 2007 | Substantially Equivalent |
| K061395 | CALSET COMPOSITE HEATER | Jun 23, 2006 | Substantially Equivalent |
| K041614 | MICROLUX DL | Apr 4, 2005 | Substantially Equivalent |