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FDA 510(k)

IMPERVA DUAL

K-Number: K913946 · 1991-12-03

ApplicantShofu Dental Corp.
Decision Date1991-12-03
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPERVA DUAL is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 1991-12-03 under 510(k) number K913946. 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 IMPERVA DUAL?

IMPERVA DUAL is a medical device that received FDA 510(k) clearance on 1991-12-03. The listed applicant is Shofu Dental Corp.. The 510(k) number is K913946.

When did IMPERVA DUAL receive FDA 510(k) clearance?

IMPERVA DUAL received FDA 510(k) clearance on 1991-12-03, under 510(k) number K913946.

Who is the listed applicant for IMPERVA DUAL?

The FDA 510(k) record lists Shofu Dental Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPERVA DUAL?

The FDA product code for IMPERVA DUAL is KLE.

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Other records listing Shofu Dental Corp. 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.

K111855HY-BOND RESIGLASSK110235BEAUTIBOND MULTIK110252BEAUTIBOND MULTI PR PLUSK101621LITE ARTK101603BEAUTIFIL FLOW PLUSK093559VINTAGE MP

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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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