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FDA 510(k)

POLY-LITE MODEL 1000

K-Number: K954061 · 1995-09-21

ApplicantPro-Den Systems, Inc.
Decision Date1995-09-21
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLY-LITE MODEL 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Den Systems, Inc.. It received FDA 510(k) clearance on 1995-09-21 under 510(k) number K954061. 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 POLY-LITE MODEL 1000?

POLY-LITE MODEL 1000 is a medical device that received FDA 510(k) clearance on 1995-09-21. The listed applicant is Pro-Den Systems, Inc.. The 510(k) number is K954061.

When did POLY-LITE MODEL 1000 receive FDA 510(k) clearance?

POLY-LITE MODEL 1000 received FDA 510(k) clearance on 1995-09-21, under 510(k) number K954061.

Who is the listed applicant for POLY-LITE MODEL 1000?

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

What is the FDA product code for POLY-LITE MODEL 1000?

The FDA product code for POLY-LITE MODEL 1000 is EBZ.

Related Clinical Trials

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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Other records listing Pro-Den Systems, 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.

K922942PRO-SCOPE MODEL # PS-4000

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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