FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
UltraPrint-Dental Temp C&B UV
K Number: K213643
·
Decision Jan 14, 2022
Classifications
1
FEI Numbers
183
Registration Numbers
183
Same Product Code
186
Applicant Total
1
Review Days
57
Basic Information
- Device Name
- UltraPrint-Dental Temp C&B UV
- K Number
- K213643
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guangzhou Heygears Imc. Inc
- Date Received
- November 18, 2021
- Decision Date
- January 14, 2022
- 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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