FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISCOVRED
K Number: K102821
·
Decision Mar 11, 2011
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
16
Applicant Total
5
Review Days
164
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Basic Information
- Device Name
- DISCOVRED
- K Number
- K102821
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1740
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phoenix Dental, Inc.
- Date Received
- September 28, 2010
- Decision Date
- March 11, 2011
- Product Code
- LFC
- 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 |
|---|---|---|---|
| LFC | Device, Caries Detection | FDA class 2 | Dental |
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Other Clearances by Phoenix Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120109 | SUPER SEAL TOOTH DESENSITIZER | Mar 7, 2012 | Substantially Equivalent |
| K983477 | SUPER SEAL | Dec 22, 1998 | Substantially Equivalent |
| K926101 | PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO | Jun 23, 1994 | Substantially Equivalent |
| K926102 | PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN | Jun 22, 1994 | Substantially Equivalent |