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FDA 510(k)

MICROPRIME

K-Number: K953504 · 1995-10-03

ApplicantDanville Engineering, Inc.
Decision Date1995-10-03
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICROPRIME is the device name listed in this FDA 510(k) record. The listed applicant is Danville Engineering, Inc.. It received FDA 510(k) clearance on 1995-10-03 under 510(k) number K953504. 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 MICROPRIME?

MICROPRIME is a medical device that received FDA 510(k) clearance on 1995-10-03. The listed applicant is Danville Engineering, Inc.. The 510(k) number is K953504.

When did MICROPRIME receive FDA 510(k) clearance?

MICROPRIME received FDA 510(k) clearance on 1995-10-03, under 510(k) number K953504.

Who is the listed applicant for MICROPRIME?

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

What is the FDA product code for MICROPRIME?

The FDA product code for MICROPRIME is KLE.

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 Danville Engineering, 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.

K970589MICROETCHER APK955445CARIES FINDERK902836MICROETCHER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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