FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
LED TURBO
K Number: K040618
·
Decision Mar 25, 2004
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
5
Review Days
16
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Basic Information
- Device Name
- LED TURBO
- K Number
- K040618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apoza Enterprise Co., Ltd.
- Date Received
- March 9, 2004
- Decision Date
- March 25, 2004
- Product Code
- EBZ
- 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | FDA class 2 | Dental |
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Other Clearances by Apoza Enterprise Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K070373 | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W | Mar 2, 2007 | Substantially Equivalent |
| K041303 | LED TURBO-PEN | Jun 18, 2004 | Substantially Equivalent |
| K033198 | APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 | Apr 30, 2004 | Substantially Equivalent |
| K033201 | LA500 BLUE LIGHT | Dec 2, 2003 | Substantially Equivalent |