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Material, Impression

FDA product code ELW · 385 cleared devices

Class 2 Dental
Regulation
21 CFR 872.3660
Review panel
DE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1976-07-21 – 2026-09-16
ELW 2025-10-31

Hydro 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);

Applicant Vigodent Indústria E Comercio Ltda

K number K253501

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