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FDA 510(k)

PROPEL Device

K-Number: K172164 · 2018-01-17

ApplicantPropel Orthodontics, LLC
Decision Date2018-01-17
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROPEL Device is a medical device manufactured by Propel Orthodontics, LLC. It received FDA 510(k) clearance on 2018-01-17 under approval number K172164. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPEL Device?

PROPEL Device is a medical device that received FDA 510(k) clearance on 2018-01-17. It is manufactured by Propel Orthodontics, LLC. The 510(k) number is K172164.

When was PROPEL Device approved by the FDA?

PROPEL Device received FDA 510(k) clearance on 2018-01-17, under approval number K172164.

What company makes PROPEL Device?

PROPEL Device is manufactured by Propel Orthodontics, LLC.

What is the FDA product code for PROPEL Device?

The FDA product code for PROPEL Device is DZJ.

Other Devices by Propel Orthodontics, LLC

K183018VPro5

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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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