FDA 510(k)

VPro5

K-Number: K183018 · 2019-11-01

Decision Date2019-11-01

Product CodeOYH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

VPro5 is the device name listed in this FDA 510(k) record. The listed applicant is Propel Orthodontics, LLC. It received FDA 510(k) clearance on 2019-11-01 under 510(k) number K183018. The device is classified under product code OYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VPro5?

VPro5 is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Propel Orthodontics, LLC. The 510(k) number is K183018.

When did VPro5 receive FDA 510(k) clearance?

VPro5 received FDA 510(k) clearance on 2019-11-01, under 510(k) number K183018.

Who is the listed applicant for VPro5?

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

What is the FDA product code for VPro5?

The FDA product code for VPro5 is OYH.

Other records listing Propel Orthodontics, LLC 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.

K172164PROPEL Device

Related Devices (Code: OYH)

K170093AcceleDent OptimaOrthoaccel Technology, Inc.K153048AcceleDent AuraOrthoaccel Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.