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FDA 510(k)

DOMINION

K-Number: K831098 · 1983-06-16

ApplicantUnitek Corp.
Decision Date1983-06-16
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DOMINION is the device name listed in this FDA 510(k) record. The listed applicant is Unitek Corp.. It received FDA 510(k) clearance on 1983-06-16 under 510(k) number K831098. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOMINION?

DOMINION is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Unitek Corp.. The 510(k) number is K831098.

When did DOMINION receive FDA 510(k) clearance?

DOMINION received FDA 510(k) clearance on 1983-06-16, under 510(k) number K831098.

Who is the listed applicant for DOMINION?

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 DOMINION?

The FDA product code for DOMINION is EJT.

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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 BRACKETK933501ALASTIKK940165ALASTIKK923999ALASTIK NSK924645TRANSCEND SERIES 6000 DEBONDING INSTRUMENTSK924295DEBRACKETING INSTRUMENT

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Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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