FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOCRYL X
K Number: K083479
·
Decision Feb 27, 2009
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
13
Review Days
95
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Basic Information
- Device Name
- BIOCRYL X
- K Number
- K083479
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Great Lakes Orthodontics, Ltd.
- Date Received
- November 24, 2008
- Decision Date
- February 27, 2009
- Product Code
- EBI
- 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
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