Premium Plus Prophy Air Motor
K-Number: K170261 · 2017-10-19
ApplicantPremium Plus International Limited
Decision Date2017-10-19
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Premium Plus Prophy Air Motor is a medical device manufactured by Premium Plus International Limited. It received FDA 510(k) clearance on 2017-10-19 under approval number K170261. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Premium Plus Prophy Air Motor?
Premium Plus Prophy Air Motor is a medical device that received FDA 510(k) clearance on 2017-10-19. It is manufactured by Premium Plus International Limited. The 510(k) number is K170261.
When was Premium Plus Prophy Air Motor approved by the FDA?
Premium Plus Prophy Air Motor received FDA 510(k) clearance on 2017-10-19, under approval number K170261.
What company makes Premium Plus Prophy Air Motor?
Premium Plus Prophy Air Motor is manufactured by Premium Plus International Limited.
What is the FDA product code for Premium Plus Prophy Air Motor?
The FDA product code for Premium Plus Prophy Air Motor is EFB.
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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.