FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VIZILITE-BLUE ORAL EXAM KIT
K Number: K033033
·
Decision Nov 22, 2004
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
22
Applicant Total
7
Review Days
423
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Basic Information
- Device Name
- VIZILITE-BLUE ORAL EXAM KIT
- K Number
- K033033
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trylon Corp.
- Date Received
- September 26, 2003
- Decision Date
- November 22, 2004
- Product Code
- EAZ
- 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 |
|---|---|---|---|
| EAZ | Light, Operating, Dental | FDA class 1 | Dental |
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| K003995 | SPECULITE/ORALLITE | Mar 16, 2001 | Substantially Equivalent |
| K963391 | SPECULITE | Dec 12, 1997 | Substantially Equivalent |
| K955790 | PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY | Mar 21, 1996 | Substantially Equivalent |
| K953364 | SPECULITE | Dec 8, 1995 | Substantially Equivalent |