Question 1

What types of medical devices does Hager Worldwide, Inc. manufacture?

Accepted Answer

Hager Worldwide, Inc. specializes in dental devices, producing both reusable and single-use instruments. Their product line includes reusable items like eye splash shields, dental mirrors, sterilization/disinfection containers, and dental impression trays. They also manufacture single-use periodontal picks and specialized systems such as dental suction systems, irrigation handpieces, and root canal posts. These devices are designed to support various dental procedures, ensuring quality and precision in clinical settings.

Question 2

Where is Hager Worldwide, Inc. based, and what does this mean for their regulatory compliance?

Accepted Answer

Hager Worldwide, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under FDA’s Class I and Class II categories. This means their products must comply with FDA requirements for safety, performance, and labeling, though individual devices—not the company—are authorized for use. The U.S. headquarters also means their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and verify regulatory compliance.

Question 3

Which regulatory registries or databases list Hager Worldwide, Inc.’s devices?

Accepted Answer

Hager Worldwide, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized way to identify medical devices, ensuring transparency in tracking and compliance. This registry helps healthcare providers, regulators, and other stakeholders verify the identity of the devices and their regulatory status, though it does not imply company-wide approval—only that individual devices meet FDA requirements for listing.

Question 4

How are Hager Worldwide, Inc.’s devices classified by the FDA, and what does this classification mean?

Accepted Answer

Hager Worldwide, Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose the lowest risk and may require general controls like proper labeling and manufacturing practices. Class II devices involve moderate risk and may require additional controls, such as performance standards or post-market surveillance. The classification determines the regulatory pathway for authorization, ensuring devices meet safety and effectiveness standards before entering the market, but it does not reflect the company’s overall approval status.

Device	Model / Reference	Registries	Class	Status
Markley Threaded Wire .032	38032	FDA UDI	Class I	Unknown
Pressure Pot - 8 quart	66041	FDA UDI	Class I	Active
Surfactant 8oz	62801	FDA UDI	Class I	Active
CATALINA WATER BATH 2000 110V Serial Number:	42904	FDA UDI	Class I	Active
Tong-Clin Gel	607035	FDA UDI	Class I	Active
Serviceable Standard	B10115	FDA UDI	Class I	Active
DuraSyringe - a-dec style W/O QUICK DISCONNECT3-WAY SYRINGE - NEW	B10556	FDA UDI	Class I	Active
SafeDispense - White	22236	FDA UDI	Class I	Active
DEL-JECT CARRIER Tip (45 Degree)	355025	FDA UDI	Class I	Active
Mirahold Plus Cheek Retractor (Adult/Child)	605452	FDA UDI	Class I	Active
Serviceable Saliva Ejector	B10112	FDA UDI	Class I	Active
Uni-Tip -Package of 100	B1633	FDA UDI	Class I	Unknown
Aspirator Adapter (saliva Ejec Converts 16mm To 11mm) (each)	254132	FDA UDI	Class I	Active
Uvex Avatar Eyewear Red Frame W/Clear Lens	356120	FDA UDI	Class I	Active
Protho Brush-Translucent- Blue- (pk-12)	607015	FDA UDI	Class I	Active
Spandex Child	605455	FDA UDI	Class I	Active
Black Gasket for 6/8 qt.Pressure Pot	66042	FDA UDI	Class I	Active
Markley Threaded Wire .035	38035	FDA UDI	Class I	Unknown
Mirror Suction - Handle (Yellow)	254061	FDA UDI	Class I	Unknown
Del-Ject Carrier (90 Degree)	355036	FDA UDI	Class I	Active
Ergo Vac Stationary	B11171S	FDA UDI	Class I	Unknown
MetaLIFT Magnum Key Replacement Part	452227	FDA UDI	Class I	Active
Happy Morning "bio" Toothbrushes (box/40)	605500	FDA UDI	Class I	Active
Hydro Vac Saliva Ejector	B11138	FDA UDI	Class I	Unknown
Bull Frog "Expert" Series Combo Kit Medium	B11202	FDA UDI	Class I	Unknown
Saliva Ejector Tip (Gray) - Pack of 3	B10108	FDA UDI	Class I	Unknown
Almore Microfil Instrument - Kit of 3	96044	FDA UDI	Class I	Active
Hager Outbacks Red	100701	FDA UDI	Class I	Active
MetaLIFT Regular Key Replacement Part	452225	FDA UDI	Class I	Active
Happy Morning Toothbrush W/Out Paste	605403	FDA UDI	Class I	Active
FLEX H.V.E. (1/2in TUBING) 25 FT.LIGHT GRAY (EACH)	B3001	FDA UDI	Class I	Active
Reso-Pac Hydrophilic Periodontal Dressing	155019	FDA UDI	Class II	Active
MetaLIFT High Speed Burs	452230	FDA UDI	Class I	Active
Bio-Guard Bulk Refill-Maintenance Pack(128 Pouches)	B2003	FDA UDI	Class I	Active
Mirabor-Fg/Ca (24 Burs)	355244	FDA UDI	Class I	Active
Bio-Guard Shock Pack (20 Pouches)	B2000	FDA UDI	Class I	Active
Bull Frog Standard	B11105	FDA UDI	Class I	Active
Focu-Tip No.9 (set/2) White Light Intensifying Tip	355088	FDA UDI	Class I	Active
Ignite Black & Silver Tinted	355827	FDA UDI	Class I	Active
Hm Xylitol Toothbrushes	605496	FDA UDI	Class I	Active
Mini SafeDispense	22231	FDA UDI	Class I	Active
Mirror Suction Single-Sided - Introductory Kit	254050	FDA UDI	Class I	Unknown
Bull Frog Expert Series Hve-Handpiece- Medium-- W/O -swivel	B11201	FDA UDI	Class I	Active
The Prepster (also known as LaminateButler)	355247	FDA UDI	Class I	Active
Endo Foam Refill Yellow/Blue	33630	FDA UDI	Class I	Active
Bio Vacuum Tip - Hygoformic	254012	FDA UDI	Class I	Active
Ergo-Vac (110 Degree H.v.e. Handpiece)without Swivel Adaptor	B11181	FDA UDI	Class I	Active
Wire Clip-On Loupe (+3)	87047	FDA UDI	Class I	Active
Algilock Solid Tray	101004	FDA UDI	Class I	Unknown
MIRROR SUCTION Double Sided HEAD (6)	254077	FDA UDI	Class I	Unknown

Hager Worldwide, Inc.

About

What Hager Worldwide, Inc. makes

Frequently asked questions

Information

Catalogue (703)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities