FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYBIRD LED CURING LIGHT
K Number: K042703
·
Decision Oct 12, 2004
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
6
Review Days
12
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Basic Information
- Device Name
- CYBIRD LED CURING LIGHT
- K Number
- K042703
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dxm Co., Ltd.
- Date Received
- September 30, 2004
- Decision Date
- October 12, 2004
- Product Code
- EBZ
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
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 Dxm Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K191221 | Cybird LED Curing Light | Jan 10, 2020 | Substantially Equivalent |
| K173876 | Cybird LED Curing Light | Jan 24, 2018 | Substantially Equivalent |
| K121093 | D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 | Nov 27, 2012 | Substantially Equivalent |
| K081694 | DENJECTOR | Sep 12, 2008 | Substantially Equivalent |
| K040116 | HAWK INTRAORAL CAMERA AND ACCESSORIES | Apr 20, 2004 | Substantially Equivalent |