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FDA 510(k)

TETRIC EVOCERAM BULK FILL

K-Number: K111958 · 2011-10-14

ApplicantIvoclar Vivadent, Inc.
Decision Date2011-10-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TETRIC EVOCERAM BULK FILL is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2011-10-14 under 510(k) number K111958. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TETRIC EVOCERAM BULK FILL?

TETRIC EVOCERAM BULK FILL is a medical device that received FDA 510(k) clearance on 2011-10-14. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K111958.

When did TETRIC EVOCERAM BULK FILL receive FDA 510(k) clearance?

TETRIC EVOCERAM BULK FILL received FDA 510(k) clearance on 2011-10-14, under 510(k) number K111958.

Who is the listed applicant for TETRIC EVOCERAM BULK FILL?

The FDA 510(k) record lists Ivoclar Vivadent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TETRIC EVOCERAM BULK FILL?

The FDA product code for TETRIC EVOCERAM BULK FILL is EBF.

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Other records listing Ivoclar Vivadent, Inc. 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.

K261485Tetric plus Fill;Tetric plus FlowK253953IPS e.max ZirconiaK252450Adhese 2K233995Ivotion Base PrintK153753TelioCAD MultiK110756BLUEPHASE STYLE

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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