K241283 is an FDA 510(k) clearance for the Elemental Granulate. This device is classified as a Oral Wound Dressing.
Submitted by Zinkh NV (Gent, BE). The FDA issued a Cleared decision on January 3, 2025, 241 days after receiving the submission on May 7, 2024.
This device falls under the Dental 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 | K241283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2024 |
| Decision Date | January 03, 2025 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| 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. |