Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ketac Universal Aplicap

K-Number: K153174 · 2016-04-13

Applicant3M Deutschland GmbH
Decision Date2016-04-13
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ketac Universal Aplicap is the device name listed in this FDA 510(k) record. The listed applicant is 3M Deutschland GmbH. It received FDA 510(k) clearance on 2016-04-13 under 510(k) number K153174. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ketac Universal Aplicap?

Ketac Universal Aplicap is a medical device that received FDA 510(k) clearance on 2016-04-13. The listed applicant is 3M Deutschland GmbH. The 510(k) number is K153174.

When did Ketac Universal Aplicap receive FDA 510(k) clearance?

Ketac Universal Aplicap received FDA 510(k) clearance on 2016-04-13, under 510(k) number K153174.

Who is the listed applicant for Ketac Universal Aplicap?

The FDA 510(k) record lists 3M Deutschland GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ketac Universal Aplicap?

The FDA product code for Ketac Universal Aplicap is EMA.

Other records listing 3M Deutschland GmbH 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.

K220257PermadyneK192992Suglue 3K192961ADH19K173318Rapid HB, Rapid LB, Rapid MBK161922XP202K151748Clean & More

View all 7 devices →

Related Devices (Code: EMA)

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.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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.

↑