Data / Medical devices / United States / Procter & Gamble Distributing LLC, The

Procter & Gamble Distributing LLC, The: FDA-registered device maker in Union, OH, United States, 11 510(k) clearances

Name: Procter & Gamble Distributing LLC, The FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Procter & Gamble Distributing LLC, The is registered with the FDA (registration 3011964664) in Union, OH, United States. It lists 20 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 18, 2019. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3011964664
Address: 1800 Union Airpark BLVD, Union, OH, United States, 45377
Owner or operator: Procter & Gamble (9915005)
Roles: Repackager or relabeler
First device listed: November 26, 1986
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Tampon, Menstrual, Scented, Scented-Deodorized	HIL	2	Repackager or relabeler	accessdata.fda.gov
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt	KOO	1	Repackager or relabeler	accessdata.fda.gov
Applicator, Ent	KCJ	1	Repackager or relabeler	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Repackager or relabeler	accessdata.fda.gov
Cup, Menstrual	HHE	2	Repackager or relabeler	accessdata.fda.gov
Dental Hygiene Kit	NXZ	1	Repackager or relabeler	accessdata.fda.gov
Floss, Dental	JES	1	Repackager or relabeler	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Repackager or relabeler	accessdata.fda.gov
Heat Source For Bleaching Teeth	EEG	1	Repackager or relabeler	accessdata.fda.gov
Light Based Over-The-Counter Hair Removal	OHT	2	Repackager or relabeler	accessdata.fda.gov
Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile	NRC	1	Repackager or relabeler	accessdata.fda.gov
Pad, Menstrual, Unscented	HHD	1	Repackager or relabeler	accessdata.fda.gov
Pick, Massaging	JET	1	Repackager or relabeler	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Repackager or relabeler	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Repackager or relabeler	accessdata.fda.gov
Scraper, Tongue	LCN	1	Repackager or relabeler	accessdata.fda.gov
Tampon, Menstrual, Unscented	HEB	2	Repackager or relabeler	accessdata.fda.gov
Tip, Rubber, Oral Hygiene	JEW	1	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Manual	EFW	1	Repackager or relabeler	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 18, 2019	K190366	BRAUN Silk Expert Pro 3	OHT	Substantially Equivalent	Cyden Limited	accessdata.fda.gov
March 18, 2019	K190354	BRAUN Silk.expert Pro 5	OHT	Substantially Equivalent	Cyden Limited	accessdata.fda.gov
November 16, 2016	K162231	iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert	OHT	Substantially Equivalent	Cyden Limited	accessdata.fda.gov
June 18, 2015	K143003	iPulse Smooth Skin Gold Hair Removal System	OHT	Substantially Equivalent	Ipulse Limited	accessdata.fda.gov
January 9, 2014	K133244	TAMPAX M PLASTIC TAMPONS, UNSCENTED	HEB	Substantially Equivalent	The Procter & Gamble Company	accessdata.fda.gov
June 20, 2013	K131543	TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED	HEB	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
June 2, 2011	K110669	TAMPAX C PLASTIC TAMPONS, UNSCENTED	HEB	Substantially Equivalent	The Procter & Gamble Co.	accessdata.fda.gov
June 27, 2008	K081555	TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED	HIL	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
August 1, 2006	K061486	TAMPAX TAMPONS - (LIGHT,REGULAR,SUPER AND SUPER PLUS ABSORBENCIES)	HEB	Substantially Equivalent	Procter & Gamble Co.	accessdata.fda.gov
June 5, 2006	K061351	ORAL-B SONIC COMPLETE	JEQ	Substantially Equivalent	Braun GmbH	accessdata.fda.gov
May 31, 2006	K061199	ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES	JEQ	Substantially Equivalent	Braun GmbH	accessdata.fda.gov

Compare with other makers

Updated March 18, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.