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FDA 510(k)

CONTACT RESIN

K-Number: K790439 · 1979-04-10

ApplicantVivadent (Usa), Inc.
Decision Date1979-04-10
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONTACT RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Vivadent (Usa), Inc.. It received FDA 510(k) clearance on 1979-04-10 under 510(k) number K790439. 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 CONTACT RESIN?

CONTACT RESIN is a medical device that received FDA 510(k) clearance on 1979-04-10. The listed applicant is Vivadent (Usa), Inc.. The 510(k) number is K790439.

When did CONTACT RESIN receive FDA 510(k) clearance?

CONTACT RESIN received FDA 510(k) clearance on 1979-04-10, under 510(k) number K790439.

Who is the listed applicant for CONTACT RESIN?

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

What is the FDA product code for CONTACT RESIN?

The FDA product code for CONTACT RESIN is EBF.

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Other records listing Vivadent (Usa), 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.

K863831VIVADENT FILPINK823409HELIOSIT-ORTHODONTICK813015HELIOSEALK802679SILANITK802681HELIOBONDK802684HELIOMAT

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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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