Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZENO PMMA DISC

K-Number: K080182 · 2008-04-08

ApplicantWieland Dental + Technik GmbH & Co. KG
Decision Date2008-04-08
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZENO PMMA DISC 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 2008-04-08 under 510(k) number K080182. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZENO PMMA DISC?

ZENO PMMA DISC is a medical device that received FDA 510(k) clearance on 2008-04-08. The listed applicant is Wieland Dental + Technik GmbH & Co. KG. The 510(k) number is K080182.

When did ZENO PMMA DISC receive FDA 510(k) clearance?

ZENO PMMA DISC received FDA 510(k) clearance on 2008-04-08, under 510(k) number K080182.

Who is the listed applicant for ZENO PMMA DISC?

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 ZENO PMMA DISC?

The FDA product code for ZENO PMMA DISC is EBG.

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 DISCK073108ZENO ZR DISC

View all 42 devices →

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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.

↑