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FDA 510(k)

UNITEK DISPOSABLE IMPRESSION SYRINGE

K-Number: K851386 · 1985-04-29

ApplicantUnitek Corp.
Decision Date1985-04-29
Product CodeEID
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNITEK DISPOSABLE IMPRESSION SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Unitek Corp.. It received FDA 510(k) clearance on 1985-04-29 under 510(k) number K851386. The device is classified under product code EID. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITEK DISPOSABLE IMPRESSION SYRINGE?

UNITEK DISPOSABLE IMPRESSION SYRINGE is a medical device that received FDA 510(k) clearance on 1985-04-29. The listed applicant is Unitek Corp.. The 510(k) number is K851386.

When did UNITEK DISPOSABLE IMPRESSION SYRINGE receive FDA 510(k) clearance?

UNITEK DISPOSABLE IMPRESSION SYRINGE received FDA 510(k) clearance on 1985-04-29, under 510(k) number K851386.

Who is the listed applicant for UNITEK DISPOSABLE IMPRESSION SYRINGE?

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 UNITEK DISPOSABLE IMPRESSION SYRINGE?

The FDA product code for UNITEK DISPOSABLE IMPRESSION SYRINGE is EID.

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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: EID)

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.

K941431BONE GRAFT DELIVERY SYRINGESBio-Interfaces, Inc.K913974ACCESS IMPRESSION BARRELCentrix, Inc.K873153CAULK'S VPS CARTRIDGE SYSTEMDentsply Intl.K871937IMPRESSION SYRINGEDentsply Intl.K863998COLTENE JET-MIXERColtene, Inc.K853282CENTRIX RIBBON TUBESCentrix, Inc.

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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