Submission Details
| 510(k) Number | K241283 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Elemental Granulate
Jan 2025
Decision
241d
Days
—
Risk
About This 510(k) Submission
K241283 is an FDA 510(k) clearance for the Elemental Granulate, 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 review panel.
Device Classification
| 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. |
Manufacturer
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