FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
K Number: K110600
·
Decision Jul 29, 2011
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
52
Applicant Total
32
Review Days
149
Basic Information
- Device Name
- COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
- K Number
- K110600
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- COLLAGEN MATRIX, INC.
- Date Received
- March 2, 2011
- Decision Date
- July 29, 2011
- Product Code
- NPL
- 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 |
|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | FDA class 2 | Dental |
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