FDA 510(k)
FDA class 2
Substantially Equivalent
🇱🇮 Liechtenstein
Adhese Universal DC, Cention Primer
K Number: K210804
·
Decision Jun 7, 2022
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
31
Review Days
447
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
- Adhese Universal DC, Cention Primer
- K Number
- K210804
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ivoclar Vivadent, AG
- Date Received
- March 17, 2021
- Decision Date
- June 7, 2022
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLE), ordered by most recent decision date.
Any-Etch
FDA 510(k)
FDA Class 2
·Dental
Porcelain Etch Gel
FDA 510(k)
FDA Class 2
·Dental
Adhese 2
FDA 510(k)
FDA Class 2
·Dental
Bond-PR Universal Adhesive
FDA 510(k)
FDA Class 2
·Dental
VITA VMLC Primer
FDA 510(k)
FDA Class 2
·Dental
els unibond
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Ivoclar Vivadent, AG
| K Number | Device Name | ||
|---|---|---|---|
| K211916 | IPS e.max One | Aug 20, 2021 | Substantially Equivalent |
| K193193 | Telio CAD Abutment Solutions- extra systems | Nov 16, 2020 | Substantially Equivalent |
| K191453 | Cervitec F | Feb 11, 2020 | Substantially Equivalent |
| K191448 | Barrier Sleeves | Oct 8, 2019 | Substantially Equivalent |
| K191382 | IPS e.max CAD Abutment Solutions- extra systems | Aug 26, 2019 | Substantially Equivalent |
| K190339 | Helioseal F Plus | Jul 29, 2019 | Substantially Equivalent |
| K190272 | Bluephase PowerCure | Jul 3, 2019 | Substantially Equivalent |
| K183380 | Tetric PowerFill | Mar 14, 2019 | Substantially Equivalent |
| K173573 | Tetric CAD | Jun 7, 2018 | Substantially Equivalent |
| K163613 | Bluephase Style 20i | Apr 4, 2017 | Substantially Equivalent |