Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1941138

FEI Number

1941138

Entity Name

YOUNG DENTAL MANUFACTURING CO 1, LLC.

City/State/Country

EARTH CITY, MO, US

Establishment Address

13705 Shoreline Ct E, EARTH CITY, MO 63045, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

Young Innovations Inc (Owner Number: 9031933)

Owner / Operator Contact Address

2260 Wendt street, Algonquin, IL 60102, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080814

PMA Number

N/A

All Registered Proprietary Names

Oral-B Centrays Disposable Fluoride Applicator Trays Oral-B Centwins Disposable Fluoride Applicator Trays Preat Athena Champion Reusable Prophy Angle Birex Disinfectant Wipes Opti-Cide 3 Opti-Cide 3 Surface Wipes Birex Plus Wipes Birex Quat Wipes Purit Cide-It Birex Quat Spray Birex SE III Johnson Promident, Challenger, Classic Athena High Speed Handpiece Biotrol Surgical Evacuation Tips Young Dental High Volume Evacuator Tips Young Infinity Cordless Handpiece System Johnson Promident ClearDefense Silver Fluoride Hypersensitivity Varnish BRUSHES AND POLISHERS DISPOSABLE PROPHYLAXIS CUPS Nyclave Dry Heat Indicator Labels Prophylaxis Angles Young Core DPAs Young Dental, Infinity, Denticator Barrier Sleeves Disclosing Solution, Disclosing Tablets RUBBER DAM HOLDER Preat Mandrel Latch Type and Straight Handpiece Oral-B 5% Sodium Fluoride Varnish Zooby Fluoride Varnish Varnish Pen 5% Sodium Fluoride Private Labeled 5% Sodium Fluoride Varnish Biocide G30 Dental Barrier Sleeves D-Lish 5% Sodium Fluoride Varnish - Fresh Melon D-Lish 5% Sodium Fluoride Varnish - Vanilla Cupcake D-Lish 5% Sodium Fluoride Varnish - Assorted D-Lish 5% Sodium Fluoride Varnish - Spearmint Surprise D-Lish 5% Sodium Fluoride Varnish - Green Apple

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2006-01-23
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-12-13
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2010-12-01
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2002-09-11
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2021-08-26
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2010-12-01
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2004-03-24
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2018-10-16
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2021-09-01
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2021-09-01
PHR	Diammine Silver Fluoride Dental Hypersensitivity Varnish	Dental	Class 2	872.3260	2025-03-05
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	1992-07-29
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2012-04-25
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2007-12-14
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2024-09-25
QJC	Plaque Disclosing Agent	Dental	Class 1	872.6855	2023-05-22
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2007-12-18
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2002-09-11
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	1992-07-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-12-13
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2007-12-17
MVL	Cord, Retraction	Unknown	Class U	N/A	2018-07-20
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2016-09-13
MED	Sterilant, Medical Devices	General Hospital	Class 2	880.6885	2007-12-17
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2017-10-20
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2007-12-18
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2014-02-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Young Innovations Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2134751	YOUNG MICROBRUSH LLC	GRAFTON, WI, US
3027615	AMERICAN EAGLE INSTRUMENTS	Missoula, MT, US
8022249	GERMIPHENE CORP.	BRANTFORD Ontario, CA
2024980	YOUNG INNOVATIONS INC.	Algonquin, IL, US
1066741	SALVIN DENTAL SPECIALTIES, LLC	CHARLOTTE, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

Similar Registrations

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3005167547	PERIO PROTECT LLC	Saint Louis, MO, US
2086043	PAC-DENT INC.	Brea, CA, US
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3010583458	ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, CN
3017903664	FSEVEN DENTAL TECHNOLOGY ZHUHAI CO.,LTD	ZHUHAI Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1941138. Last updated year: 2026. Please use registration number 1941138 when referencing this establishment in official correspondence.