FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHODONTIC BRACES
K Number: K981433
·
Decision Jun 25, 1998
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
41
Applicant Total
7
Review Days
66
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Basic Information
- Device Name
- ORTHODONTIC BRACES
- K Number
- K981433
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Midwest Orthodontic Mfg.
- Date Received
- April 20, 1998
- Decision Date
- June 25, 1998
- Product Code
- DYW
- 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 |
|---|---|---|---|
| DYW | Bracket, Plastic, Orthodontic | FDA class 2 | Dental |
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Other Clearances by Midwest Orthodontic Mfg.
| K Number | Device Name | ||
|---|---|---|---|
| K955740 | GLUFLORMA | Feb 8, 1996 | Substantially Equivalent |
| K952856 | LIGHT-CURE PC | Sep 12, 1995 | Substantially Equivalent |
| K952855 | PC-LOCK | Sep 8, 1995 | Substantially Equivalent |
| K952857 | PRO-LOCK | Sep 5, 1995 | Substantially Equivalent |
| K952858 | LIGHT-CURE | Sep 5, 1995 | Substantially Equivalent |
| K900824 | FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) | May 22, 1990 | Substantially Equivalent |