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)

SURGICAL CURETTE, VARIOUS

K-Number: K841004 · 1984-05-11

ApplicantPremier Dental Products Co.
Decision Date1984-05-11
Product CodeHCY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SURGICAL CURETTE, VARIOUS is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Co.. It received FDA 510(k) clearance on 1984-05-11 under 510(k) number K841004. The device is classified under product code HCY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL CURETTE, VARIOUS?

SURGICAL CURETTE, VARIOUS is a medical device that received FDA 510(k) clearance on 1984-05-11. The listed applicant is Premier Dental Products Co.. The 510(k) number is K841004.

When did SURGICAL CURETTE, VARIOUS receive FDA 510(k) clearance?

SURGICAL CURETTE, VARIOUS received FDA 510(k) clearance on 1984-05-11, under 510(k) number K841004.

Who is the listed applicant for SURGICAL CURETTE, VARIOUS?

The FDA 510(k) record lists Premier Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL CURETTE, VARIOUS?

The FDA product code for SURGICAL CURETTE, VARIOUS is HCY.

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 Premier Dental Products Co. 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.

K132526KNIT-PAK+K131212PREMIER CERAMIC PRIMERK083695TRAXODENTK062683ENAMEL PRO VARNISHK062166ENAMEL PROK061998PREMIER SELF-ETCHING BOND ENHANCER

View all 40 devices →

Related Devices (Code: HCY)

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.

K980096OAC (OPTICAL ASPIRATING CURETTE)Imagyn Medical Technologies, Inc.K944238ENDOCYTE TMD.L. Nelson and Assoc., Inc.K935822PHASE I CURETTEPhase I Corp.K901442BAXTER D & C TRAYBaxter Healthcare CorpK890384UTERINE CURETTEKinetic Medical ProductsK881794IVORY FINDER SETIvory Instruments Co.

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.

↑