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FDA 510(k)

IN TEN-S

K-Number: K011492 · 2001-07-05

ApplicantIvoclar North America, Inc.
Decision Date2001-07-05
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IN TEN-S 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 2001-07-05 under 510(k) number K011492. 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 IN TEN-S?

IN TEN-S is a medical device that received FDA 510(k) clearance on 2001-07-05. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K011492.

When did IN TEN-S receive FDA 510(k) clearance?

IN TEN-S received FDA 510(k) clearance on 2001-07-05, under 510(k) number K011492.

Who is the listed applicant for IN TEN-S?

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 IN TEN-S?

The FDA product code for IN TEN-S is EBF.

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 CHROMAK011490MODIFICATION TO EXCITEK011023D.SIGN 96K011022BIOUNIVERSAL PDFK010381D.SIGN 30

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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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