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FDA 510(k)

IPS e.max CAD Abutment Solutions- extra systems

K-Number: K191382 · 2019-08-26

ApplicantIvoclar Vivadent, AG
Decision Date2019-08-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IPS e.max CAD Abutment Solutions- extra systems is a medical device manufactured by Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2019-08-26 under approval number K191382. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IPS e.max CAD Abutment Solutions- extra systems?

IPS e.max CAD Abutment Solutions- extra systems is a medical device that received FDA 510(k) clearance on 2019-08-26. It is manufactured by Ivoclar Vivadent, AG. The 510(k) number is K191382.

When was IPS e.max CAD Abutment Solutions- extra systems approved by the FDA?

IPS e.max CAD Abutment Solutions- extra systems received FDA 510(k) clearance on 2019-08-26, under approval number K191382.

What company makes IPS e.max CAD Abutment Solutions- extra systems?

IPS e.max CAD Abutment Solutions- extra systems is manufactured by Ivoclar Vivadent, AG.

What is the FDA product code for IPS e.max CAD Abutment Solutions- extra systems?

The FDA product code for IPS e.max CAD Abutment Solutions- extra systems is NHA.

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Related PubMed Literature

PMID: 41513582 Medical devices for professional use: What assessment, what funding? Therapie (2026) PMID: 40495026 Artificial Intelligence (AI) Facts Labels: An Innovative Disclosure Tool Promoting Patient-Centric Transparency in Healthcare AI Systems. Journal of medical systems (2025)

Other Devices by Ivoclar Vivadent, AG

K160798IPS e.max® Press Abutment Solutions for Viteo Base Ti K152103IPS Style Ceram, IPS Style Ceram One, IPS Style Press K163613Bluephase Style 20i K173573Tetric CAD K191448Barrier Sleeves K190339Helioseal F Plus

View all 13 devices →

Related Devices (Code: NHA)

K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd. K160798IPS e.max® Press Abutment Solutions for Viteo Base TiIvoclar Vivadent, AG K162004PREMIUM Implant Systems SHELTA Implant SystemsSweden & Martina S.P.A. K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd. K161435Temporary Snap AbutmentNobel Biocare AB K160786RODO Abutment SystemRodo Medical, Inc.

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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