FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCS-B COLLAGEN
K Number: K142040
·
Decision Jul 31, 2015
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
39
Applicant Total
3
Review Days
368
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Basic Information
- Device Name
- OCS-B COLLAGEN
- K Number
- K142040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nibec Co., Ltd.
- Date Received
- July 28, 2014
- Decision Date
- July 31, 2015
- Product Code
- NPM
- 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 |
|---|---|---|---|
| NPM | Bone Grafting Material, Animal Source | FDA class 2 | Dental |
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