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FDA 510(k)

GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO

K-Number: K112575 · 2011-12-27

ApplicantGeistlich Pharma AG
Decision Date2011-12-27
Product CodeNPM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2011-12-27 under 510(k) number K112575. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO?

GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO is a medical device that received FDA 510(k) clearance on 2011-12-27. The listed applicant is Geistlich Pharma AG. The 510(k) number is K112575.

When did GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO receive FDA 510(k) clearance?

GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO received FDA 510(k) clearance on 2011-12-27, under 510(k) number K112575.

Who is the listed applicant for GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO?

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

What is the FDA product code for GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO?

The FDA product code for GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO is NPM.

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Other records listing Geistlich Pharma AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: NPM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254210REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)Hyundai Bioland Co., Ltd.K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AGK251613SwissGraft XGeistlich Pharma AGK242510Geistlich Bio-Flow®Geistlich Pharma AGK240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLC

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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