FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
PMMA BLOCK
K Number: K141421
·
Decision Feb 9, 2015
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
3
Review Days
255
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Basic Information
- Device Name
- PMMA BLOCK
- K Number
- K141421
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rizhao Huge Dental Industry Co., Ltd.
- Date Received
- May 30, 2014
- Decision Date
- February 9, 2015
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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