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FDA 510(k)

REMESENSE FOR SENSITIVE TEETH

K-Number: K122708 · 2013-01-14

ApplicantSylphar N.V.
Decision Date2013-01-14
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REMESENSE FOR SENSITIVE TEETH is the device name listed in this FDA 510(k) record. The listed applicant is Sylphar N.V.. It received FDA 510(k) clearance on 2013-01-14 under 510(k) number K122708. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMESENSE FOR SENSITIVE TEETH?

REMESENSE FOR SENSITIVE TEETH is a medical device that received FDA 510(k) clearance on 2013-01-14. The listed applicant is Sylphar N.V.. The 510(k) number is K122708.

When did REMESENSE FOR SENSITIVE TEETH receive FDA 510(k) clearance?

REMESENSE FOR SENSITIVE TEETH received FDA 510(k) clearance on 2013-01-14, under 510(k) number K122708.

Who is the listed applicant for REMESENSE FOR SENSITIVE TEETH?

The FDA 510(k) record lists Sylphar N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REMESENSE FOR SENSITIVE TEETH?

The FDA product code for REMESENSE FOR SENSITIVE TEETH is LBH.

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Related Devices (Code: LBH)

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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.

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