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FDA 510(k)

FLOSS HOLDER (PLASTIC)

K-Number: K855113 · 1986-03-06

ApplicantPacific Union Dental, Inc.
Decision Date1986-03-06
Product CodeJES
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLOSS HOLDER (PLASTIC) is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Union Dental, Inc.. It received FDA 510(k) clearance on 1986-03-06 under 510(k) number K855113. 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 FLOSS HOLDER (PLASTIC)?

FLOSS HOLDER (PLASTIC) is a medical device that received FDA 510(k) clearance on 1986-03-06. The listed applicant is Pacific Union Dental, Inc.. The 510(k) number is K855113.

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

FLOSS HOLDER (PLASTIC) received FDA 510(k) clearance on 1986-03-06, under 510(k) number K855113.

Who is the listed applicant for FLOSS HOLDER (PLASTIC)?

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

What is the FDA product code for FLOSS HOLDER (PLASTIC)?

The FDA product code for FLOSS HOLDER (PLASTIC) 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.

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Other records listing Pacific Union Dental, 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.

K863500STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CARK860817ROOT CANAL ORGANIZERK855112DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYSK855111DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES

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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