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FDA 510(k)

GREAT LAKES PASTE SOLDER

K-Number: K832425 · 1983-10-04

ApplicantGreat Lakes Orthodontics, Ltd.
Decision Date1983-10-04
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GREAT LAKES PASTE SOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Great Lakes Orthodontics, Ltd.. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K832425. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GREAT LAKES PASTE SOLDER?

GREAT LAKES PASTE SOLDER is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Great Lakes Orthodontics, Ltd.. The 510(k) number is K832425.

When did GREAT LAKES PASTE SOLDER receive FDA 510(k) clearance?

GREAT LAKES PASTE SOLDER received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832425.

Who is the listed applicant for GREAT LAKES PASTE SOLDER?

The FDA 510(k) record lists Great Lakes Orthodontics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GREAT LAKES PASTE SOLDER?

The FDA product code for GREAT LAKES PASTE SOLDER is EJS.

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Other records listing Great Lakes Orthodontics, Ltd. as applicant

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Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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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