FDA 510(k)
FDA class 2
Substantially Equivalent
🇱🇮 Liechtenstein
Barrier Sleeves
K Number: K191448
·
Decision Oct 8, 2019
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
14
Applicant Total
31
Review Days
130
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
- Barrier Sleeves
- K Number
- K191448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ivoclar Vivadent, AG
- Date Received
- May 31, 2019
- Decision Date
- October 8, 2019
- Product Code
- PEM
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| PEM | Dental Barriers And Sleeves | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PEM), ordered by most recent decision date.
Dental Barrier and Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dental Barrier and Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dental Barrier and Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dental Barrier and Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Disposable Barrier Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Minitube Dentasleeve Protective Barrier Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Ivoclar Vivadent, AG
| K Number | Device Name | ||
|---|---|---|---|
| K210804 | Adhese Universal DC, Cention Primer | Jun 7, 2022 | Substantially Equivalent |
| 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 |
| 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 |