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FDA 510(k)

ORAL-B ULTRAFLOSS WITH FLLUORIDE

K-Number: K943157 · 1995-04-27

ApplicantOral-B Laboratories
Decision Date1995-04-27
Product CodeJES
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORAL-B ULTRAFLOSS WITH FLLUORIDE is the device name listed in this FDA 510(k) record. The listed applicant is Oral-B Laboratories. It received FDA 510(k) clearance on 1995-04-27 under 510(k) number K943157. 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 ORAL-B ULTRAFLOSS WITH FLLUORIDE?

ORAL-B ULTRAFLOSS WITH FLLUORIDE is a medical device that received FDA 510(k) clearance on 1995-04-27. The listed applicant is Oral-B Laboratories. The 510(k) number is K943157.

When did ORAL-B ULTRAFLOSS WITH FLLUORIDE receive FDA 510(k) clearance?

ORAL-B ULTRAFLOSS WITH FLLUORIDE received FDA 510(k) clearance on 1995-04-27, under 510(k) number K943157.

Who is the listed applicant for ORAL-B ULTRAFLOSS WITH FLLUORIDE?

The FDA 510(k) record lists Oral-B Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAL-B ULTRAFLOSS WITH FLLUORIDE?

The FDA product code for ORAL-B ULTRAFLOSS WITH FLLUORIDE is JES.

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Other records listing Oral-B Laboratories 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.

K942633ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDEK943182ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATORK932990ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUPK925408ORAL-B DENTAL TAPE WITH FLUORIDEK925409ORAL-B DENTAL FLOSS WITH FLUORIDEK913603FIBRETWINS

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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.

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