FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
LYSTA LC CURING LIGHT, MODEL LC 2500C/BA
K Number: K991138
·
Decision Apr 23, 1999
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
2
Review Days
18
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
- LYSTA LC CURING LIGHT, MODEL LC 2500C/BA
- K Number
- K991138
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lysta A/S
- Date Received
- April 5, 1999
- Decision Date
- April 23, 1999
- 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
Other Clearances by Lysta A/S
| K Number | Device Name | ||
|---|---|---|---|
| K992236 | LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA | Aug 27, 1999 | Substantially Equivalent |