FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
ISOLIGHT
K Number: K894059
·
Decision Sep 7, 1989
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
22
Applicant Total
5
Review Days
92
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Basic Information
- Device Name
- ISOLIGHT
- K Number
- K894059
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Eurodent, Inc.
- Date Received
- June 7, 1989
- Decision Date
- September 7, 1989
- Product Code
- EAZ
- 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 |
|---|---|---|---|
| EAZ | Light, Operating, Dental | FDA class 1 | Dental |
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