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FDA 510(k)

CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO

K-Number: K113282 · 2012-09-20

ApplicantRiemser Arzeimittel AG
Decision Date2012-09-20
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO is the device name listed in this FDA 510(k) record. The listed applicant is Riemser Arzeimittel AG. It received FDA 510(k) clearance on 2012-09-20 under 510(k) number K113282. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO?

CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO is a medical device that received FDA 510(k) clearance on 2012-09-20. The listed applicant is Riemser Arzeimittel AG. The 510(k) number is K113282.

When did CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO receive FDA 510(k) clearance?

CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO received FDA 510(k) clearance on 2012-09-20, under 510(k) number K113282.

Who is the listed applicant for CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO?

The FDA 510(k) record lists Riemser Arzeimittel AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO?

The FDA product code for CERASORB DENTAL,CERADORB M DENTAL, CERASORB PERIO is LYC.

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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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