FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADAPTABLE CLASS III MASK
K Number: K861424
·
Decision May 29, 1986
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
35
Applicant Total
13
Review Days
43
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Basic Information
- Device Name
- ADAPTABLE CLASS III MASK
- K Number
- K861424
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5500
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Great Lakes Orthodontics, Ltd.
- Date Received
- April 16, 1986
- Decision Date
- May 29, 1986
- Product Code
- DZB
- 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 |
|---|---|---|---|
| DZB | Headgear, Extraoral, Orthodontic | FDA class 2 | Dental |
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| K041718 | KELES FACEMASK | Oct 15, 2004 | Substantially Equivalent |
| K040881 | METACRYL | May 25, 2004 | Substantially Equivalent |
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| K922818 | SNORE-NO-MORE | Feb 9, 1994 | Substantially Equivalent |
| K925275 | SOFT DENTURE RELINE MATERIAL ELASTOLINE | Jan 11, 1993 | Substantially Equivalent |
| K870908 | STEADY RESIN | Mar 19, 1987 | Substantially Equivalent |
| K840805 | ORAL SAFE | Mar 30, 1984 | Substantially Equivalent |