Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FIXIDENT

K-Number: K821629 · 1982-06-14

ApplicantMoyco Industries, Inc.
Decision Date1982-06-14
Product CodeJET
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIXIDENT is the device name listed in this FDA 510(k) record. The listed applicant is Moyco Industries, Inc.. It received FDA 510(k) clearance on 1982-06-14 under 510(k) number K821629. The device is classified under product code JET. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXIDENT?

FIXIDENT is a medical device that received FDA 510(k) clearance on 1982-06-14. The listed applicant is Moyco Industries, Inc.. The 510(k) number is K821629.

When did FIXIDENT receive FDA 510(k) clearance?

FIXIDENT received FDA 510(k) clearance on 1982-06-14, under 510(k) number K821629.

Who is the listed applicant for FIXIDENT?

The FDA 510(k) record lists Moyco Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIXIDENT?

The FDA product code for FIXIDENT is JET.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Moyco Industries, Inc. 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.

K932511SILICONE MIRRORK833558X-RAY SHIELDK821444COLORED WEDGE USED TO SEPARATE TEETHK810839SPOTARK810912ALLOY COMPOSITE POLISH

Related Devices (Code: JET)

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.

K963747REACH STIM-U-DENT PLAQUE REMOVERS WITH MICRODENT/REACH FLOSS STIKS WITH MICRODENT/REACH FLOSS PICS WITH MICRODENT ETC.Whitehill Manufacturing, Inc.K942633ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDEOral-B LaboratoriesK930178ELECTRO FLOSSArizona Implant DentistryK911418GUM MASSAGERBurn-Henderson PartnershipK885189MASSAGING PICK FOR ORAL HYGIENEDentek Corp.K890910PLAKOFXimex, Ltd.

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.

↑