FDA 510(k)

X-704

K-Number: K832253 · 1983-08-31

Decision Date1983-08-31

Product CodeEJS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

X-704 is the device name listed in this FDA 510(k) record. The listed applicant is Unitek Corp.. It received FDA 510(k) clearance on 1983-08-31 under 510(k) number K832253. 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 X-704?

X-704 is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Unitek Corp.. The 510(k) number is K832253.

When did X-704 receive FDA 510(k) clearance?

X-704 received FDA 510(k) clearance on 1983-08-31, under 510(k) number K832253.

Who is the listed applicant for X-704?

The FDA 510(k) record lists Unitek Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-704?

The FDA product code for X-704 is EJS.

Other records listing Unitek Corp. 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.

K944286METAL-LINED TRANSCEND CERAMIC BRACKET K933501ALASTIK K940165ALASTIK K923999ALASTIK NS K924645TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS K924295DEBRACKETING INSTRUMENT

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Related Devices (Code: EJS)

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KG K022252STERNGOLD 1, MODEL 1127781Sterngold K022469ECO E4Wieland Dental + Technik GmbH & Co. KG K021367STERNGOLD 66, MODEL #1180230Sterngold K020195SIMIDUR 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.