FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIDWEST LIGHT WAND
K Number: K820693
·
Decision Apr 9, 1982
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
213
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- MIDWEST LIGHT WAND
- K Number
- K820693
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- American Midwest
- Date Received
- March 12, 1982
- Decision Date
- April 9, 1982
- 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 American Midwest
| K Number | Device Name | ||
|---|---|---|---|
| K821895 | AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR | Jul 16, 1982 | Substantially Equivalent |
| K821715 | AM-40 SYSTEM | Jun 25, 1982 | Substantially Equivalent |
| K811979 | ATT-1 DENTAL COMPOSITE RESTORATIVE SYS | Aug 18, 1981 | Substantially Equivalent |
| K800735 | U-STYLE ADAPTER | Apr 10, 1980 | Substantially Equivalent |