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FDA 510(k)

TONGUE HOLDER/SALIVA EJECTOR

K-Number: K800210 · 1980-02-06

ApplicantUnitek Corp.
Decision Date1980-02-06
Product CodeDYN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TONGUE HOLDER/SALIVA EJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Unitek Corp.. It received FDA 510(k) clearance on 1980-02-06 under 510(k) number K800210. The device is classified under product code DYN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TONGUE HOLDER/SALIVA EJECTOR?

TONGUE HOLDER/SALIVA EJECTOR is a medical device that received FDA 510(k) clearance on 1980-02-06. The listed applicant is Unitek Corp.. The 510(k) number is K800210.

When did TONGUE HOLDER/SALIVA EJECTOR receive FDA 510(k) clearance?

TONGUE HOLDER/SALIVA EJECTOR received FDA 510(k) clearance on 1980-02-06, under 510(k) number K800210.

Who is the listed applicant for TONGUE HOLDER/SALIVA EJECTOR?

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 TONGUE HOLDER/SALIVA EJECTOR?

The FDA product code for TONGUE HOLDER/SALIVA EJECTOR is DYN.

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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: DYN)

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.

K940769DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTORTerraflexK935758HYGOFLEX SALIVA-EJECTORJ.H.Orsing ABK935616SALIVA EJECTOR DISPOSABLEAsa Instruments S.R.L.K924211EJECTORGlenroe TechnologiesK920492HIGH VACHygoplastic, Inc.K921117MINIDAMDelsan Dental Systems

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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