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FDA 510(k)

TETRIC CERAM HB

K-Number: K010250 · 2001-02-28

ApplicantIvoclar North America, Inc.
Decision Date2001-02-28
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TETRIC CERAM HB is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 2001-02-28 under 510(k) number K010250. 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 CERAM HB?

TETRIC CERAM HB is a medical device that received FDA 510(k) clearance on 2001-02-28. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K010250.

When did TETRIC CERAM HB receive FDA 510(k) clearance?

TETRIC CERAM HB received FDA 510(k) clearance on 2001-02-28, under 510(k) number K010250.

Who is the listed applicant for TETRIC CERAM HB?

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

What is the FDA product code for TETRIC CERAM HB?

The FDA product code for TETRIC CERAM HB is EBF.

Related Clinical Trials

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.

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Other records listing Ivoclar North America, 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.

K012174ERIS LAYERING MATERIALSK011491HELIOSEAL CLEAR CHROMAK011492IN TEN-SK011490MODIFICATION TO EXCITEK011023D.SIGN 96K011022BIOUNIVERSAL PDF

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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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