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FDA 510(k)

SIMIDUR S2

K-Number: K020192 · 2002-03-15

ApplicantWieland Dental + Technik GmbH & Co. KG
Decision Date2002-03-15
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIMIDUR S2 is the device name listed in this FDA 510(k) record. The listed applicant is Wieland Dental + Technik GmbH & Co. KG. It received FDA 510(k) clearance on 2002-03-15 under 510(k) number K020192. 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 SIMIDUR S2?

SIMIDUR S2 is a medical device that received FDA 510(k) clearance on 2002-03-15. The listed applicant is Wieland Dental + Technik GmbH & Co. KG. The 510(k) number is K020192.

When did SIMIDUR S2 receive FDA 510(k) clearance?

SIMIDUR S2 received FDA 510(k) clearance on 2002-03-15, under 510(k) number K020192.

Who is the listed applicant for SIMIDUR S2?

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

What is the FDA product code for SIMIDUR S2?

The FDA product code for SIMIDUR S2 is EJS.

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Other records listing Wieland Dental + Technik GmbH & Co. KG 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.

K130184ZENOLUXK112710ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZRK103773ZENOFLEX DIMENSIONK103494ZENOSTAR MAGIC GLAZEK082257ZENO AI ECO DISCK080182ZENO PMMA DISC

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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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