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FDA 510(k)

SILJETR SYSTEM

K-Number: K110642 · 2011-05-27

ApplicantDanville Materials, Inc.
Decision Date2011-05-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SILJETR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Danville Materials, Inc.. It received FDA 510(k) clearance on 2011-05-27 under 510(k) number K110642. 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 SILJETR SYSTEM?

SILJETR SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-27. The listed applicant is Danville Materials, Inc.. The 510(k) number is K110642.

When did SILJETR SYSTEM receive FDA 510(k) clearance?

SILJETR SYSTEM received FDA 510(k) clearance on 2011-05-27, under 510(k) number K110642.

Who is the listed applicant for SILJETR SYSTEM?

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

What is the FDA product code for SILJETR SYSTEM?

The FDA product code for SILJETR SYSTEM is EBF.

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Other records listing Danville Materials, 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.

K121880DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUIDK111876Z BOND, PRELUDE ONEK102753TURBO TEMP 3K092912STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150K092319STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387K090106PRELUDE ONE

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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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