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FDA 510(k)

RACESTYPTINE

K-Number: K884653 · 1989-01-19

ApplicantSpecialites Septodont
Decision Date1989-01-19
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RACESTYPTINE is the device name listed in this FDA 510(k) record. The listed applicant is Specialites Septodont. It received FDA 510(k) clearance on 1989-01-19 under 510(k) number K884653. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RACESTYPTINE?

RACESTYPTINE is a medical device that received FDA 510(k) clearance on 1989-01-19. The listed applicant is Specialites Septodont. The 510(k) number is K884653.

When did RACESTYPTINE receive FDA 510(k) clearance?

RACESTYPTINE received FDA 510(k) clearance on 1989-01-19, under 510(k) number K884653.

Who is the listed applicant for RACESTYPTINE?

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

What is the FDA product code for RACESTYPTINE?

The FDA product code for RACESTYPTINE is EKJ.

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Other records listing Specialites Septodont 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.

K012427PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENTK010415ISODANK982773QUICKSET LIQUID AND POWDERK982671SECURALLOYK980633ENDOSOLV EK920692SEPTOCALCINE ULTRA

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Related Devices (Code: EKJ)

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.

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K953707MEDTROL DENTAL KITMedtrol, Inc.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943820STAT PAKMagnum Instruments, 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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