FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHODONTIC ELASTICS BANDS
K Number: K920645
·
Decision Jul 28, 1992
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
102
Applicant Total
4
Review Days
167
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Basic Information
- Device Name
- ORTHODONTIC ELASTICS BANDS
- K Number
- K920645
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Masel Industries, Inc.
- Date Received
- February 12, 1992
- Decision Date
- July 28, 1992
- Product Code
- EJF
- 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 |
|---|---|---|---|
| EJF | Bracket, Metal, Orthodontic | FDA class 1 | Dental |
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