FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA
K Number: K992236
·
Decision Aug 27, 1999
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
2
Review Days
56
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Basic Information
- Device Name
- LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA
- K Number
- K992236
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lysta A/S
- Date Received
- July 2, 1999
- Decision Date
- August 27, 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 |
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Other Clearances by Lysta A/S
| K Number | Device Name | ||
|---|---|---|---|
| K991138 | LYSTA LC CURING LIGHT, MODEL LC 2500C/BA | Apr 23, 1999 | Substantially Equivalent |