FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRENGLOO
K Number: K061481
·
Decision Jul 6, 2006
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
40
Review Days
37
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Basic Information
- Device Name
- GRENGLOO
- K Number
- K061481
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ormco Corp.
- Date Received
- May 30, 2006
- Decision Date
- July 6, 2006
- Product Code
- DYH
- 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | FDA class 2 | Dental |
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