Elevate Oral Care
Elevate Oral Care appears in FDA public data with 2 recalls, 5 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0627-2026, Class II) was initiated on June 4, 2026. Its most recent 510(k) clearance was granted on February 27, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 5
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0627-2026 | Class II | Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Su | June 4, 2026 |
| D-0658-2024 | Class III | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufacture | August 20, 2024 |