W&H Assistina Twin
K-Number: K171553 · 2017-12-08
ApplicantW&H Dentalwerk Buermoos GmbH
Decision Date2017-12-08
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
W&H Assistina Twin is a medical device manufactured by W&H Dentalwerk Buermoos GmbH. It received FDA 510(k) clearance on 2017-12-08 under approval number K171553. 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 W&H Assistina Twin?
W&H Assistina Twin is a medical device that received FDA 510(k) clearance on 2017-12-08. It is manufactured by W&H Dentalwerk Buermoos GmbH. The 510(k) number is K171553.
When was W&H Assistina Twin approved by the FDA?
W&H Assistina Twin received FDA 510(k) clearance on 2017-12-08, under approval number K171553.
What company makes W&H Assistina Twin?
W&H Assistina Twin is manufactured by W&H Dentalwerk Buermoos GmbH.
What is the FDA product code for W&H Assistina Twin?
The FDA product code for W&H Assistina Twin 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.