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FDA 510(k)

PVS DUAL CURE VENEER BONDING KIT

K-Number: K894391 · 1989-09-19

ApplicantJelenko Co.
Decision Date1989-09-19
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PVS DUAL CURE VENEER BONDING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Jelenko Co.. It received FDA 510(k) clearance on 1989-09-19 under 510(k) number K894391. 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 PVS DUAL CURE VENEER BONDING KIT?

PVS DUAL CURE VENEER BONDING KIT is a medical device that received FDA 510(k) clearance on 1989-09-19. The listed applicant is Jelenko Co.. The 510(k) number is K894391.

When did PVS DUAL CURE VENEER BONDING KIT receive FDA 510(k) clearance?

PVS DUAL CURE VENEER BONDING KIT received FDA 510(k) clearance on 1989-09-19, under 510(k) number K894391.

Who is the listed applicant for PVS DUAL CURE VENEER BONDING KIT?

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

What is the FDA product code for PVS DUAL CURE VENEER BONDING KIT?

The FDA product code for PVS DUAL CURE VENEER BONDING KIT is KLE.

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Other records listing Jelenko Co. 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.

K010416HERACERAM 75K003603BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HEK984164JELBOND NPK964158JEL-40 (CODE NAME RD-0430)K930762SUPERSTARK912195PA-396 GOLD BASED/PRECIOUS METAL ALLOYS CLIN USE

View all 12 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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