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FDA 510(k)

DTX Studio Clinic (4.0)

K-Number: K231898 · 2023-12-08

ApplicantNobel Biocare AB
Decision Date2023-12-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DTX Studio Clinic (4.0) is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare AB. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K231898. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DTX Studio Clinic (4.0)?

DTX Studio Clinic (4.0) is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Nobel Biocare AB. The 510(k) number is K231898.

When did DTX Studio Clinic (4.0) receive FDA 510(k) clearance?

DTX Studio Clinic (4.0) received FDA 510(k) clearance on 2023-12-08, under 510(k) number K231898.

Who is the listed applicant for DTX Studio Clinic (4.0)?

The FDA 510(k) record lists Nobel Biocare AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DTX Studio Clinic (4.0)?

The FDA product code for DTX Studio Clinic (4.0) is LLZ.

Other records listing Nobel Biocare AB as applicant

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Related Devices (Code: LLZ)

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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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