FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI ADJUSTABLE FACE MASK
K Number: K000358
·
Decision Jun 9, 2000
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
35
Applicant Total
2
Review Days
126
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Basic Information
- Device Name
- MULTI ADJUSTABLE FACE MASK
- K Number
- K000358
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5500
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ortho Technology
- Date Received
- February 4, 2000
- Decision Date
- June 9, 2000
- 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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Other Clearances by Ortho Technology
| K Number | Device Name | ||
|---|---|---|---|
| K051751 | EQUA-PULL SAFETY RELEASE MODULE | Jul 22, 2005 | Substantially Equivalent |