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FDA 510(k)

DENTAL FLOSS

K-Number: K912430 · 1991-09-30

ApplicantWestone Products , Ltd.
Decision Date1991-09-30
Product CodeJES
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL FLOSS is the device name listed in this FDA 510(k) record. The listed applicant is Westone Products , Ltd.. It received FDA 510(k) clearance on 1991-09-30 under 510(k) number K912430. 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?

DENTAL FLOSS is a medical device that received FDA 510(k) clearance on 1991-09-30. The listed applicant is Westone Products , Ltd.. The 510(k) number is K912430.

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

DENTAL FLOSS received FDA 510(k) clearance on 1991-09-30, under 510(k) number K912430.

Who is the listed applicant for DENTAL FLOSS?

The FDA 510(k) record lists Westone Products , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL FLOSS?

The FDA product code for DENTAL FLOSS 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 Westone Products , Ltd. 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.

K913087DENTAL FLOSSK864832DENTAL FLOSS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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