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FDA 510(k)

ESTILUX UV SYSTEM

K-Number: K770113 · 1977-01-28

ApplicantDegussa Dental, Inc.
Decision Date1977-01-28
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESTILUX UV SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Degussa Dental, Inc.. It received FDA 510(k) clearance on 1977-01-28 under 510(k) number K770113. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTILUX UV SYSTEM?

ESTILUX UV SYSTEM is a medical device that received FDA 510(k) clearance on 1977-01-28. The listed applicant is Degussa Dental, Inc.. The 510(k) number is K770113.

When did ESTILUX UV SYSTEM receive FDA 510(k) clearance?

ESTILUX UV SYSTEM received FDA 510(k) clearance on 1977-01-28, under 510(k) number K770113.

Who is the listed applicant for ESTILUX UV SYSTEM?

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

What is the FDA product code for ESTILUX UV SYSTEM?

The FDA product code for ESTILUX UV SYSTEM is EBZ.

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Other records listing Degussa Dental, 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.

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Related Devices (Code: EBZ)

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.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

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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