FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
Allcem, Allcem Core
K Number: K183465
·
Decision Nov 2, 2019
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
10
Review Days
323
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
- Allcem, Allcem Core
- K Number
- K183465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentscare Ltda
- Date Received
- December 14, 2018
- Decision Date
- November 2, 2019
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMA), ordered by most recent decision date.
G-CEM UNIVERSAL
FDA 510(k)
FDA Class 2
·Dental
REGEN Bioactive Cement
FDA 510(k)
FDA Class 2
·Dental
Bifix Veneer LC, Bifix Veneer Try-In
FDA 510(k)
FDA Class 2
·Dental
iCEM Universal Plus
FDA 510(k)
FDA Class 2
·Dental
TopCEM Vigor SA Self-Adhesive Resin Cement
FDA 510(k)
FDA Class 2
·Dental
GlasIonomer FX-LC
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Dentscare Ltda
| K Number | Device Name | ||
|---|---|---|---|
| K231859 | PrimmaArt | Nov 26, 2024 | Substantially Equivalent |
| K232994 | Vittra APS Unique Flow | Oct 18, 2024 | Substantially Equivalent |
| K210231 | Vittra APS Unique | Oct 14, 2021 | Substantially Equivalent |
| K201707 | Opallis, Opallis Flow | Dec 22, 2020 | Substantially Equivalent |
| K192682 | Orthocem, Ortho Bite | Aug 14, 2020 | Substantially Equivalent |
| K191389 | Allcem Veneer APS | Feb 25, 2020 | Substantially Equivalent |
| K191306 | Llis, Vittra APS | Dec 16, 2019 | Substantially Equivalent |
| K183424 | Ambar, Ambar APS, Ambar Universal APS | Dec 13, 2019 | Substantially Equivalent |
| K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | Sep 4, 2019 | Substantially Equivalent |