FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
LEDEX WL070+
K Number: K163605
·
Decision Jan 19, 2017
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
4
Review Days
29
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LEDEX WL070+
- K Number
- K163605
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dentmate Technology Co. , Ltd.
- Date Received
- December 21, 2016
- Decision Date
- January 19, 2017
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBZ), ordered by most recent decision date.
Curing Light (M-Cure 6)
FDA 510(k)
FDA Class 2
·Dental
Demi Pro
FDA 510(k)
FDA Class 2
·Dental
Bluemoon
FDA 510(k)
FDA Class 2
·Dental
LED Curing Lights (DB686 HALO)
FDA 510(k)
FDA Class 2
·Dental
LED Curing Light (C01-X, C02-X)
FDA 510(k)
FDA Class 2
·Dental
LOOP LED Curing Light System (CLK01)
FDA 510(k)
FDA Class 2
·Dental