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FDA 510(k)

HELIOMAT

K-Number: K802684 · 1980-11-24

ApplicantVivadent (Usa), Inc.
Decision Date1980-11-24
Product CodeEAY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HELIOMAT 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 1980-11-24 under 510(k) number K802684. The device is classified under product code EAY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELIOMAT?

HELIOMAT is a medical device that received FDA 510(k) clearance on 1980-11-24. The listed applicant is Vivadent (Usa), Inc.. The 510(k) number is K802684.

When did HELIOMAT receive FDA 510(k) clearance?

HELIOMAT received FDA 510(k) clearance on 1980-11-24, under 510(k) number K802684.

Who is the listed applicant for HELIOMAT?

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 HELIOMAT?

The FDA product code for HELIOMAT is EAY.

Related Clinical Trials

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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-ORTHODONTICK813015HELIOSEALK802679SILANITK802682CONTACT SEALK802683HELIOSIT

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Related Devices (Code: EAY)

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.

K953191MODEL A15-101Beaverstate Dental, Inc.K953192MODEL A15-103Beaverstate Dental, Inc.K935718JEDENTAL VLC DENTAL CURING LIGHTJedental Co., Inc.K871816STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TMStryker Corp.K831976POWER OPTICRitter Co.K831824DENTAL ELECTRONIC/S.B.R TRADING BU HANDSilverman'S

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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