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FDA 510(k)

DUO PAL 6, ORDER-NO.: 2154

K-Number: K012841 · 2001-11-20

ApplicantWieland Edelmetalle GmbH & Co.
Decision Date2001-11-20
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DUO PAL 6, ORDER-NO.: 2154 is the device name listed in this FDA 510(k) record. The listed applicant is Wieland Edelmetalle GmbH & Co.. It received FDA 510(k) clearance on 2001-11-20 under 510(k) number K012841. 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 DUO PAL 6, ORDER-NO.: 2154?

DUO PAL 6, ORDER-NO.: 2154 is a medical device that received FDA 510(k) clearance on 2001-11-20. The listed applicant is Wieland Edelmetalle GmbH & Co.. The 510(k) number is K012841.

When did DUO PAL 6, ORDER-NO.: 2154 receive FDA 510(k) clearance?

DUO PAL 6, ORDER-NO.: 2154 received FDA 510(k) clearance on 2001-11-20, under 510(k) number K012841.

Who is the listed applicant for DUO PAL 6, ORDER-NO.: 2154?

The FDA 510(k) record lists Wieland Edelmetalle GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUO PAL 6, ORDER-NO.: 2154?

The FDA product code for DUO PAL 6, ORDER-NO.: 2154 is EJS.

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Other records listing Wieland Edelmetalle GmbH & Co. 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.

K020347AGC SPEZIALLEGIERUNGK012839AUROPAL, ORDER-NO.: 2101K012843PORTADUR P 2, MODEL #2031K012834PORTA GEO TI MODEL #2004K012827PORTA AURIUM, MODEL 2067K012828PORTA SMK 82, MODEL 2032

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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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