Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 a medical device manufactured by 3M Deutschland GmbH. It received FDA 510(k) clearance on 2016-04-13 under approval 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. It is manufactured by 3M Deutschland GmbH. The 510(k) number is K153174.

When was Ketac Universal Aplicap approved by the FDA?

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

What company makes Ketac Universal Aplicap?

Ketac Universal Aplicap is manufactured by 3M Deutschland GmbH.

What is the FDA product code for Ketac Universal Aplicap?

The FDA product code for Ketac Universal Aplicap is EMA.

Other Devices by 3M Deutschland GmbH

K161922XP202 K151748Clean & More K173318Rapid HB, Rapid LB, Rapid MB K192992Suglue 3 K192961ADH19 K220257Permadyne

View all 7 devices →

Related Devices (Code: EMA)

K160800DuoCemColtene/Whaledent AG K161851Glass Ionomer Cement (Luting)Shandong Huge Dental Material Corporation K160443TempoCem ClearDmg USA, Inc. K160774IonoStar PlusVoco GmbH K161256TheraCemBisco, Inc. K153231G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi PrimerGC America, Inc.

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.

↑