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FDA 510(k)

COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE

K-Number: K912994 · 1991-12-23

ApplicantWilde-USA, Inc.
Decision Date1991-12-23
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Wilde-USA, Inc.. It received FDA 510(k) clearance on 1991-12-23 under 510(k) number K912994. 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 COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE?

COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE is a medical device that received FDA 510(k) clearance on 1991-12-23. The listed applicant is Wilde-USA, Inc.. The 510(k) number is K912994.

When did COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE receive FDA 510(k) clearance?

COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE received FDA 510(k) clearance on 1991-12-23, under 510(k) number K912994.

Who is the listed applicant for COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE?

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

What is the FDA product code for COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE?

The FDA product code for COMPALUX STROBOSCOPIC LIGHT POLYMERIZATION DEVICE is EBZ.

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Other records listing Wilde-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.

K913582COMPATIT RK915653KERAMAILK913581WILDE ADHESIVE BONDING SYSTEMK923472COMPACOLORK920649COMPASEPK915250WIL-PDS & WIL-PDI CASTING ALLOYS

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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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