K211026 is an FDA 510(k) clearance for the Minitube Dentasleeve Protective Barrier Sleeves. This device is classified as a Dental Barriers And Sleeves (Class II - Special Controls, product code PEM).
Submitted by Minitube AB (Trångsviken, SE). The FDA issued a Cleared decision on August 3, 2021, 119 days after receiving the submission on April 6, 2021.
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 | K211026 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2021 |
| Decision Date | August 03, 2021 |
| Days to Decision | 119 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. |