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FDA 510(k)

Dia-X Sil Heavy Body

K-Number: K254142 · 2026-09-16

ApplicantDiaDent Group International
Decision Date2026-09-16
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dia-X Sil Heavy Body is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K254142. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dia-X Sil Heavy Body?

Dia-X Sil Heavy Body is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is DiaDent Group International. The 510(k) number is K254142.

When did Dia-X Sil Heavy Body receive FDA 510(k) clearance?

Dia-X Sil Heavy Body received FDA 510(k) clearance on 2026-09-16, under 510(k) number K254142.

Who is the listed applicant for Dia-X Sil Heavy Body?

The FDA 510(k) record lists DiaDent Group International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dia-X Sil Heavy Body?

The FDA product code for Dia-X Sil Heavy Body is ELW.

Other records listing DiaDent Group International as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254152Dia-X Sil Light BodyK261166DIA-CEMK261093DIAFILK261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)K254112Dia-X Sil BiteK231552Dia-Cem

View all 23 devices →

Related Devices (Code: ELW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254152Dia-X Sil Light BodyDiaDent Group InternationalK254112Dia-X Sil BiteDiaDent Group InternationalK253501Hydro 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);Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , Ltd.K242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal ActivatorDent4you AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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