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)

DENTAL FLOSS HOLDER

K-Number: K831254 · 1983-05-09

ApplicantSewon Industry
Decision Date1983-05-09
Product CodeJES
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL FLOSS HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Sewon Industry. It received FDA 510(k) clearance on 1983-05-09 under 510(k) number K831254. The device is classified under product code JES. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL FLOSS HOLDER?

DENTAL FLOSS HOLDER is a medical device that received FDA 510(k) clearance on 1983-05-09. The listed applicant is Sewon Industry. The 510(k) number is K831254.

When did DENTAL FLOSS HOLDER receive FDA 510(k) clearance?

DENTAL FLOSS HOLDER received FDA 510(k) clearance on 1983-05-09, under 510(k) number K831254.

Who is the listed applicant for DENTAL FLOSS HOLDER?

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

What is the FDA product code for DENTAL FLOSS HOLDER?

The FDA product code for DENTAL FLOSS HOLDER is JES.

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 Sewon Industry 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.

K870996SEWON DENTAL FLOSSERK860769DENTAL FLOSS HOLDERK842846SEWON DENTAL FLOSS FOLDERK813248DENTAL FLOSS HOLDERK811926SE WON(ALUMINUM) DENTAL FLOSS HOLDERK811555DENTAL FLOSS HOLDER

View all 7 devices →

Related Devices (Code: JES)

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.

K091964CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSSProcter & Gamble Co.K964976FLOSSBRUSH WITH FLUORIDEFlossbrush Interdental Cleaner and ApplicatorK963746IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORIDWhitehill Oral Technologies, Inc.K944034PERIO-MED DENTAL FLOSSWhitehill Oral Technologies, Inc.K952091VUTLER G.U.M. WITH FLUORIDEJohn O. Butler Co.K951917JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSSJohnson & Johnson Consumer Products, 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.

↑