FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
TEMP MASTER, PMMA-based dental resin
K Number: K243951
·
Decision Feb 21, 2025
Classifications
1
FEI Numbers
183
Registration Numbers
183
Same Product Code
186
Applicant Total
1
Review Days
60
Basic Information
- Device Name
- TEMP MASTER, PMMA-based dental resin
- K Number
- K243951
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Taiwan Dental Materials CO., LTD.
- Date Received
- December 23, 2024
- Decision Date
- February 21, 2025
- 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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