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FDA 510(k)

HEATED GUTTA PERCHA DELIVERY SYSTEM

K-Number: K832654 · 1983-09-26

ApplicantUnitek Corp.
Decision Date1983-09-26
Product CodeEKM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HEATED GUTTA PERCHA DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Unitek Corp.. It received FDA 510(k) clearance on 1983-09-26 under 510(k) number K832654. The device is classified under product code EKM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEATED GUTTA PERCHA DELIVERY SYSTEM?

HEATED GUTTA PERCHA DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1983-09-26. The listed applicant is Unitek Corp.. The 510(k) number is K832654.

When did HEATED GUTTA PERCHA DELIVERY SYSTEM receive FDA 510(k) clearance?

HEATED GUTTA PERCHA DELIVERY SYSTEM received FDA 510(k) clearance on 1983-09-26, under 510(k) number K832654.

Who is the listed applicant for HEATED GUTTA PERCHA DELIVERY SYSTEM?

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 HEATED GUTTA PERCHA DELIVERY SYSTEM?

The FDA product code for HEATED GUTTA PERCHA DELIVERY SYSTEM is EKM.

Related Clinical Trials

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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: EKM)

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.

K073369EI DOWNPAK BARRIER SLEEVESHu-Friedy Mfg. Co., Inc.K070246DOWN PAKEndo Twinn B.V.K051573TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)Dr. Howard Martin, P.A.K042870ENDO TWINNEndo Twinn B.V.K023819FIBERFILL SGPPentron Clinical TechnologiesK971641ANTIBACTERIAL GUTTA PERCHADr. Howard Martin, P.A.

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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