FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
AA temp temporary restoration 3D printing photoreactive resin
K Number: K191590
·
Decision May 5, 2020
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
2
Review Days
326
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AA temp temporary restoration 3D printing photoreactive resin
- K Number
- K191590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Enlighten Materials Co., Ltd.
- Date Received
- June 14, 2019
- Decision Date
- May 5, 2020
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBG), ordered by most recent decision date.
Dura-Arch
FDA 510(k)
FDA Class 2
·Dental
FLNT Base and FLNT Temp
FDA 510(k)
FDA Class 2
·Dental
TempFIT Temporary Crown and Bridge Resin
FDA 510(k)
FDA Class 2
·Dental
DentaTOOTH
FDA 510(k)
FDA Class 2
·Dental
Evoblock, Perléon
FDA 510(k)
FDA Class 2
·Dental
TEMP MASTER, PMMA-based dental resin
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Enlighten Materials Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K191591 | BB Base 3D printing resin for denture base | Aug 18, 2020 | Substantially Equivalent |