FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PREFORMED TEMPLATE FOR TOOTH POSITIONER
K Number: K891328
·
Decision Mar 31, 1989
Classifications
1
FEI Numbers
112
Registration Numbers
112
Same Product Code
11
Applicant Total
45
Review Days
21
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Basic Information
- Device Name
- PREFORMED TEMPLATE FOR TOOTH POSITIONER
- K Number
- K891328
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5525
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- American Orthodontics
- Date Received
- March 10, 1989
- Decision Date
- March 31, 1989
- Product Code
- KMY
- 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 |
|---|---|---|---|
| KMY | Positioner, Tooth, Preformed | FDA class 1 | Dental |
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