FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
U-STYLE ADAPTER
K Number: K800735
·
Decision Apr 10, 1980
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
5
Review Days
8
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Basic Information
- Device Name
- U-STYLE ADAPTER
- K Number
- K800735
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- American Midwest
- Date Received
- April 2, 1980
- Decision Date
- April 10, 1980
- Product Code
- EGS
- 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 |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | 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 |
| K820693 | MIDWEST LIGHT WAND | Apr 9, 1982 | Substantially Equivalent |
| K811979 | ATT-1 DENTAL COMPOSITE RESTORATIVE SYS | Aug 18, 1981 | Substantially Equivalent |