Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Dia-X Sil Bite

K-Number: K254112 · 2026-03-19

ApplicantDiaDent Group International
Decision Date2026-03-19
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dia-X Sil Bite is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2026-03-19 under approval number K254112. 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 Bite?

Dia-X Sil Bite is a medical device that received FDA 510(k) clearance on 2026-03-19. It is manufactured by DiaDent Group International. The 510(k) number is K254112.

When was Dia-X Sil Bite approved by the FDA?

Dia-X Sil Bite received FDA 510(k) clearance on 2026-03-19, under approval number K254112.

What company makes Dia-X Sil Bite?

Dia-X Sil Bite is manufactured by DiaDent Group International.

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

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

Other Devices by DiaDent Group International

K182009Dia-Proseal K182625Diapex Plus K200174DIA-ROOT BIO MTA K200809D-LUX+ K200175DIA-ROOT BIO Sealer K192392DiaPlus

View all 18 devices →

Related Devices (Code: ELW)

K152615Vonflex SVericom Co., Ltd. K161774i-SilSpident Co., Ltd. K160097Image Fast Set, Image Regular SetSybron Dental Specialties K160441Identic and KromaFaze Alginate Dental Impression MaterialsKerr Corporation K152826NoCordCentrix, Inc. K152766CharmFlexDentkist, Inc.

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.

↑