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FDA 510(k)

NUGOLD 2%

K-Number: K926145 · 1993-05-05

ApplicantJeneric/Pentron, Inc.
Decision Date1993-05-05
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUGOLD 2% 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 1993-05-05 under 510(k) number K926145. 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 NUGOLD 2%?

NUGOLD 2% is a medical device that received FDA 510(k) clearance on 1993-05-05. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K926145.

When did NUGOLD 2% receive FDA 510(k) clearance?

NUGOLD 2% received FDA 510(k) clearance on 1993-05-05, under 510(k) number K926145.

Who is the listed applicant for NUGOLD 2%?

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 NUGOLD 2%?

The FDA product code for NUGOLD 2% is EJS.

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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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