Rosetta SM, Rosetta SP— 510(k) K260859
Substantially EquivalentHass Corp.
FDA 510(k) clearance K260859 for Rosetta SM, Rosetta SP, Substantially Equivalent on 2026-06-11. Applicant: Hass Corp.. Device class: 2.
Summary
Hass Corp.'s clearance covers Rosetta SM and Rosetta SP, filed under EIH, porcelain powder. The record doesn't say what "SM" and "SP" refer to.
Class II, 21 CFR 872.6660. Dental is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Hass filed from Gangneung-Si, South Korea. The decision came 87 calendar days after receipt (March 16 to June 11, 2026).
Clearance details
- Applicant
- Hass Corp.
- Product code
- Product code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gangneung-Si, KR
Recent devices under product code EIH
view allMore clearances from Hass Corp.
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