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FDA 510(k)

KOLYNOS DENTAL FLOSS

K-Number: K882571 · 1988-10-12

ApplicantWhitehall Laboratories, Inc.
Decision Date1988-10-12
Product CodeJES
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KOLYNOS DENTAL FLOSS is the device name listed in this FDA 510(k) record. The listed applicant is Whitehall Laboratories, Inc.. It received FDA 510(k) clearance on 1988-10-12 under 510(k) number K882571. 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 KOLYNOS DENTAL FLOSS?

KOLYNOS DENTAL FLOSS is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Whitehall Laboratories, Inc.. The 510(k) number is K882571.

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

KOLYNOS DENTAL FLOSS received FDA 510(k) clearance on 1988-10-12, under 510(k) number K882571.

Who is the listed applicant for KOLYNOS DENTAL FLOSS?

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

What is the FDA product code for KOLYNOS DENTAL FLOSS?

The FDA product code for KOLYNOS 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.

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Other records listing Whitehall Laboratories, 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.

K882572DOCTOR KOLYNOS TOOTHBRUSH

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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