FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)
K Number: K900824
·
Decision May 22, 1990
Classifications
1
FEI Numbers
160
Registration Numbers
160
Same Product Code
102
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)
- K Number
- K900824
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.5410
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Midwest Orthodontic Mfg.
- Date Received
- February 21, 1990
- Decision Date
- May 22, 1990
- 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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Other Clearances by Midwest Orthodontic Mfg.
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|---|---|---|---|
| K981433 | ORTHODONTIC BRACES | Jun 25, 1998 | Substantially Equivalent |
| 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 |