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FDA 510(k)

CU-FREE & LTA

K-Number: K934757 · 1994-02-04

ApplicantJeneric/Pentron, Inc.
Decision Date1994-02-04
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CU-FREE & LTA is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 1994-02-04 under 510(k) number K934757. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CU-FREE & LTA?

CU-FREE & LTA is a medical device that received FDA 510(k) clearance on 1994-02-04. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K934757.

When did CU-FREE & LTA receive FDA 510(k) clearance?

CU-FREE & LTA received FDA 510(k) clearance on 1994-02-04, under 510(k) number K934757.

Who is the listed applicant for CU-FREE & LTA?

The FDA 510(k) record lists Jeneric/Pentron, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CU-FREE & LTA?

The FDA product code for CU-FREE & LTA is EJS.

Other records listing Jeneric/Pentron, Inc. as applicant

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Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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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