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FDA 510(k)

Clevaligner Software (V1.0.0)

K-Number: K233616 · 2024-01-11

ApplicantClevaligner, Ltd.
Decision Date2024-01-11
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Clevaligner Software (V1.0.0) is the device name listed in this FDA 510(k) record. The listed applicant is Clevaligner, Ltd.. It received FDA 510(k) clearance on 2024-01-11 under 510(k) number K233616. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Clevaligner Software (V1.0.0)?

Clevaligner Software (V1.0.0) is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is Clevaligner, Ltd.. The 510(k) number is K233616.

When did Clevaligner Software (V1.0.0) receive FDA 510(k) clearance?

Clevaligner Software (V1.0.0) received FDA 510(k) clearance on 2024-01-11, under 510(k) number K233616.

Who is the listed applicant for Clevaligner Software (V1.0.0)?

The FDA 510(k) record lists Clevaligner, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clevaligner Software (V1.0.0)?

The FDA product code for Clevaligner Software (V1.0.0) is PNN.

Related Devices (Code: PNN)

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.

K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd.K253565SureSmile SoftwareDentsply Sirona, Inc.K252507SmileInspectorAmv Consulting, LLCK253343Celebrace SoftwareCelebraceK250198Laon OrthoLaon Medi, Inc.K241153Progressive Orthodontics AppProgressive Aligners, 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.

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