FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT
K Number: K895085
·
Decision Apr 2, 1990
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
3
Review Days
231
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
- WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT
- K Number
- K895085
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Lustgarten Multi-Tech International, Inc.
- Date Received
- August 14, 1989
- Decision Date
- April 2, 1990
- 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