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FDA 510(k)

PRELUDE ONE

K-Number: K090106 · 2009-03-31

ApplicantDanville Materials, Inc.
Decision Date2009-03-31
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRELUDE ONE 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 2009-03-31 under 510(k) number K090106. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRELUDE ONE?

PRELUDE ONE is a medical device that received FDA 510(k) clearance on 2009-03-31. The listed applicant is Danville Materials, Inc.. The 510(k) number is K090106.

When did PRELUDE ONE receive FDA 510(k) clearance?

PRELUDE ONE received FDA 510(k) clearance on 2009-03-31, under 510(k) number K090106.

Who is the listed applicant for PRELUDE ONE?

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 PRELUDE ONE?

The FDA product code for PRELUDE ONE is KLE.

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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 ONEK110642SILJETR SYSTEMK102753TURBO 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 89387

View all 11 devices →

Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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