K191448 is an FDA 510(k) clearance for the Barrier Sleeves. This device is classified as a Dental Barriers And Sleeves (Class II - Special Controls, product code PEM).
Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on October 8, 2019, 130 days after receiving the submission on May 31, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 878.4370. Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients..
| 510(k) Number | K191448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2019 |
| Decision Date | October 08, 2019 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PEM — Dental Barriers And Sleeves |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4370 |
| Definition | Intended To Serve As A Disposable Barrier For Dental Instruments To Reduce The Risk Of Cross Contamination Between Dental Patients. |