FDA · official record K253501Substantially EquivalentHydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);
United StatesELWVigodent Indústria E Comercio Ltda
Official record identity
- FDA application number
- K253501
- Decision date
- October 31, 2025
- Published decision
- Substantially Equivalent
Classification
Published parties
- Applicant
- Vigodent Indústria E Comercio Ltda
Additional source fields
- Decision code
- SESE
- Published decision
- Substantially Equivalent
- Submission type
- Traditional
- Received date
- 2025-10-30
- Review panel
- Dental
- Current product-code class (harmonized)
- 2
- Current product-code regulation (harmonized)
- 872.3660
About this record
This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.