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FDA 510(k)

DentaTOOTH

K-Number: K243370 · 2025-05-05

ApplicantAsiga Pty, Ltd.
Decision Date2025-05-05
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DentaTOOTH is a medical device manufactured by Asiga Pty, Ltd.. It received FDA 510(k) clearance on 2025-05-05 under approval number K243370. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DentaTOOTH?

DentaTOOTH is a medical device that received FDA 510(k) clearance on 2025-05-05. It is manufactured by Asiga Pty, Ltd.. The 510(k) number is K243370.

When was DentaTOOTH approved by the FDA?

DentaTOOTH received FDA 510(k) clearance on 2025-05-05, under approval number K243370.

What company makes DentaTOOTH?

DentaTOOTH is manufactured by Asiga Pty, Ltd..

What is the FDA product code for DentaTOOTH?

The FDA product code for DentaTOOTH is EBG.

Other Devices by Asiga Pty, Ltd.

K243356Asiga DentaBASE

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K153490DD medical polymersDental Direkt GmbH K152443Vericore Gradient Temporary DiscWhip Mix Corporation K153753TelioCAD MultiIvoclar Vivadent, Inc. K152215DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLORDentalplus GmbH K171729Fixtemp C&BDreve Dentamid GmbH K172281PuRE PMMA DiscQuest Dental USA Corp.

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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