FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPAL BAND CEMENT
K Number: K111696
·
Decision Sep 7, 2011
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
103
Review Days
82
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Basic Information
- Device Name
- OPAL BAND CEMENT
- K Number
- K111696
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultradent Products, Inc.
- Date Received
- June 17, 2011
- Decision Date
- September 7, 2011
- 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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