K210211 is an FDA 510(k) clearance for the PuraStat-OM. This device is classified as a Oral Wound Dressing.
Submitted by 3-D Matrix, Inc. (Newton, US). The FDA issued a Cleared decision on October 8, 2021, 254 days after receiving the submission on January 27, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq..
| 510(k) Number | K210211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2021 |
| Decision Date | October 08, 2021 |
| Days to Decision | 254 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OLR - Oral Wound Dressing |
| Device Class | - |
| Definition | Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per Se To Mgq. |