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FDA 510(k)

Straumann PrefGel

K-Number: K162311 · 2017-03-07

ApplicantInstitut Straumann AG
Decision Date2017-03-07
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

Straumann PrefGel is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2017-03-07 under 510(k) number K162311. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann PrefGel?

Straumann PrefGel is a medical device that received FDA 510(k) clearance on 2017-03-07. The listed applicant is Institut Straumann AG. The 510(k) number is K162311.

When did Straumann PrefGel receive FDA 510(k) clearance?

Straumann PrefGel received FDA 510(k) clearance on 2017-03-07, under 510(k) number K162311.

Who is the listed applicant for Straumann PrefGel?

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

What is the FDA product code for Straumann PrefGel?

The FDA product code for Straumann PrefGel is KJJ.

Other records listing Institut Straumann AG as applicant

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Related Devices (Code: KJJ)

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.

K250279RC-SwiftPrepBelport Company, Inc., Gingi-PakK241354Sealer SolventInter-Med, Inc.K201785EPIEN Dental CleanserEpien Medical, Inc.K211813TritonInter-Med / Vista DentalK193357V-MixInter-Med/Vista Dental ProductsK193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products

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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