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)

PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE

K-Number: K870797 · 1987-05-01

ApplicantSafco Dental Supply
Decision Date1987-05-01
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Safco Dental Supply. It received FDA 510(k) clearance on 1987-05-01 under 510(k) number K870797. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE?

PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE is a medical device that received FDA 510(k) clearance on 1987-05-01. The listed applicant is Safco Dental Supply. The 510(k) number is K870797.

When did PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE receive FDA 510(k) clearance?

PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE received FDA 510(k) clearance on 1987-05-01, under 510(k) number K870797.

Who is the listed applicant for PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE?

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

What is the FDA product code for PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE?

The FDA product code for PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE is EKX.

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

Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis Co., 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.

↑