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
Impla Clean- Number 1	355224	FDA UDI	Class I	Unknown
BurButler ( 10 Hole Blue Base w/Lid)	355256	FDA UDI	Class I	Active
Markley Threaded Wire .064	38064	FDA UDI	Class I	Unknown
Almore Microfil Instrument - Set of 3	96044	FDA UDI	Class I	Unknown
Focu-Tip No.9.5 (set/2) White Light Intensifying Tip	355086	FDA UDI	Class I	Active
Tong-Clin Set 1 Tong Clin Deluxe & Gel	607037	FDA UDI	Class I	Active
I-Prox L (white) Pk Of 6	630212	FDA UDI	Class I	Active
MetaLIFT Magnum Removal Instrument Replacement Part	452223	FDA UDI	Class I	Active
Bullfrog "expert" Series Hve 110 Degree W/O Swivel	B11211	FDA UDI	Class I	Active
Bull Frog "Expert" Series Starter Kit	B11180	FDA UDI	Class I	Unknown
DURA SYRINGE 3-WAY SYRINGE-adec STYLE WITH QUICK DISCONNECT	B10552	FDA UDI	Class I	Active
Mirror Suction Double-Sided Red Yellow with Head	254073	FDA UDI	Class I	Unknown
Mirabor-Fg (18 Burs)-	355231	FDA UDI	Class I	Active
Hager Jewels Felines Clear	100930	FDA UDI	Class I	Active
Bull Frog "Expert" Series Short	B11195	FDA UDI	Class I	Unknown
Almore Microfil Instrument - Blue	96043	FDA UDI	Class I	Unknown
Ignite Black & Silver Clear Lens	355825	FDA UDI	Class I	Active
Mirafill (box/5)-	355439	FDA UDI	Class I	Active
MIRAFIT WHITE POST REFILL, L4, (PK/6)1.50MM x 20MM, GLASS FIBER	356047	FDA UDI	Class I	Active
Almore Inlay Wax (blue) 1 Lb.	42613	FDA UDI	Class I	Active
Bull Frog "Expert" Series Short	B11195	FDA UDI	Class I	Active
Impla Clean Plastic Implant Instrument Kit	355220	FDA UDI	Class I	Unknown
Saliva Ejector Tip (Gray) - Pack of 10	B10105	FDA UDI	Class I	Unknown
Bull Frog "Expert" Series 110 HVE (Stationary Head)	B11210S	FDA UDI	Class I	Unknown
Reamers (1-6)-Long	355997	FDA UDI	Class I	Active
Saliva Ejector Tubing 25 Ft. (each)	B3009	FDA UDI	Class I	Active
Algilock Perforated Trays	101038	FDA UDI	Class I	Unknown
Mini Vac Saliva Ejector Valve Body Only (stainless Steel)	B22260	FDA UDI	Class I	Active
Compo-Blitz Normal (thickness: 1.5mm) Normal (12pcs.)	503320	FDA UDI	Class I	Active
Markley Threaded Wire .069	38069	FDA UDI	Class I	Unknown
Waxing Instrument #6 Black	304056	FDA UDI	Class I	Active
Mirasucto Tips White	254020	FDA UDI	Class I	Active
Trollfoil D/S Blue (100)	72075	FDA UDI	Class I	Active
Mirapost Dental Post Refills M-5	355986	FDA UDI	Class I	Active
Replacment Lens 1.5 Magnifiers	355856	FDA UDI	Class I	Active
Mylar Foil - S/S BLACK - 7/8"	72006	FDA UDI	Class I	Active
SafeDispense - Silver	22230	FDA UDI	Class I	Active
Replacment Lens 2.5 Magnifiers	355860	FDA UDI	Class I	Active
Madam Butterfly Silk 3/4" Blue	72001	FDA UDI	Class I	Active
Mirror Suction - Adapter (11mm)	254065	FDA UDI	Class I	Active
Algilock Solid Tray	101042	FDA UDI	Class I	Active
Bull Frog Standard H.v.e. Handpiecew/O Swivel Adaptor	B11107	FDA UDI	Class I	Active
Blue Boa DE	254090	FDA UDI	Class I	Active
Hager Outbacks Hot Pink	100703	FDA UDI	Class I	Active
Knife Tip For Blue Microfil	96047	FDA UDI	Class I	Active
Impla Clean- Number 1	355221	FDA UDI	Class I	Unknown
Bur-Tainer/Bur Cassette-Holds 7 Burs-Blue #1464 (each)	B1500BL	FDA UDI	Class I	Active
Econo Tips-Purple (100/Pk)micro Applicators	605154	FDA UDI	Class I	Active
MetaLIFT Long Key Replacement Part	452226	FDA UDI	Class I	Active
Mirahold Adult	605450	FDA UDI	Class I	Active

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