FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERACIA SA
K Number: K113426
·
Decision Feb 8, 2012
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
54
Applicant Total
20
Review Days
82
Basic Information
- Device Name
- VERACIA SA
- K Number
- K113426
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3590
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SHOFU DENTAL CORPORATION
- Date Received
- November 18, 2011
- Decision Date
- February 8, 2012
- Product Code
- ELM
- 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 |
|---|---|---|---|
| ELM | Denture, Plastic, Teeth | FDA class 2 | Dental |
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|---|---|---|---|
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| K152451 | VINTAGE Art LF | Dec 11, 2015 | Substantially Equivalent |
| K151699 | BEAUTIFIL II Enamel | Dec 10, 2015 | Substantially Equivalent |
| K132748 | BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK | Dec 4, 2013 | Substantially Equivalent |
| K132141 | BEAUTIFIL BULK FLOWABLE | Oct 3, 2013 | Substantially Equivalent |
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