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FDA 510(k)

ULab Systems Treatment Planning Software

K-Number: K171295 · 2018-01-09

ApplicantUlab Systems, Inc.
Decision Date2018-01-09
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULab Systems Treatment Planning Software is the device name listed in this FDA 510(k) record. The listed applicant is Ulab Systems, Inc.. It received FDA 510(k) clearance on 2018-01-09 under 510(k) number K171295. 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 ULab Systems Treatment Planning Software?

ULab Systems Treatment Planning Software is a medical device that received FDA 510(k) clearance on 2018-01-09. The listed applicant is Ulab Systems, Inc.. The 510(k) number is K171295.

When did ULab Systems Treatment Planning Software receive FDA 510(k) clearance?

ULab Systems Treatment Planning Software received FDA 510(k) clearance on 2018-01-09, under 510(k) number K171295.

Who is the listed applicant for ULab Systems Treatment Planning Software?

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

What is the FDA product code for ULab Systems Treatment Planning Software?

The FDA product code for ULab Systems Treatment Planning Software is PNN.

Other records listing Ulab Systems, Inc. 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.

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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

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