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
Mirafill (#5)/(#4)-Big Spatula Instrument	355444	FDA UDI	Class I	Active
Air/Water Syringe Tubing 7 Ft. (each)light Gray	B3015	FDA UDI	Class I	Active
Bull Frog Se Valve Body Only (each)	B11124	FDA UDI	Class I	Active
Zahn Pick Soft +	605638	FDA UDI	Class I	Unknown
Markley Threaded Wire .030	38030	FDA UDI	Class I	Unknown
Algilock Solid Tray	101043	FDA UDI	Class I	Active
Safe Dispense Cutter Blade	22232	FDA UDI	Class I	Active
Madam Butterfly Silk 3/4" Grn	72002	FDA UDI	Class I	Active
Protho Brush Deluxe - Pink (single)	607024	FDA UDI	Class I	Active
MIRROR SUCTION Double Sided HEAD (1)	254076	FDA UDI	Class I	Active
SafeDispense - Dual	22238	FDA UDI	Class I	Active
Econo Tips-Orange (100/Pk)micro Applicators (	605152	FDA UDI	Class I	Active
Vapor Ii Ultra Lite/Black /clear	355505	FDA UDI	Class I	Active
Mirror Suction Single-Sided Gray Handle with Head	254055	FDA UDI	Class I	Active
Hager Prophy Angle - Soft Cup	605385	FDA UDI	Class I	Active
Mirror Suction Double-Sided - Handle (Blue)	254081	FDA UDI	Class I	Active
Soft Lining Trimmer - 110 volt	63700	FDA UDI	Class I	Active
Crown Click Deluxe Set With 3 Tips	452205	FDA UDI	Class I	Active
Quad Ring Seal	10901	FDA UDI	Class I	Active
Mirafit White Glass Fiber Post Stnd. Kit(18) Asst. L2, L3, L4, Anterior	356044	FDA UDI	Class I	Active
Access-Tips -Package of 3	B1631	FDA UDI	Class I	Active
Richwil Crown & Bridge Remover	33800	FDA UDI	Class I	Active
Almore Base Plate Wax (pink)	42604	FDA UDI	Class I	Active
Bur-Tainer/Bur Cassette-Holds 7 Burs -black (each)	B1500BK	FDA UDI	Class I	Active
BurButler ( 25 Hole Blue Base w/Lid)	355262	FDA UDI	Class I	Active
OCCLU-SPOT OCCLUSION SPRAY (75ml)GREEN, NON-TOXIC, CFC-FREE	554205	FDA UDI	Class I	Active
Shimstock Strips (300 strips)	72070	FDA UDI	Class I	Active
Uni-Wedge Regular Orange (250)	83852	FDA UDI	Class I	Active
Mirabrush Blue Straight	605431	FDA UDI	Class II	Active
Ultra-Vac H.v.e. Handpiece-Aluminumultra-Vac Without Swivel (each)	B11153	FDA UDI	Class I	Active
Replacement Lens 3.0 Magnifiers	355862	FDA UDI	Class I	Active
Ultra Vac	B11150	FDA UDI	Class I	Active
Paddle Tip for Gold Microfil	96045	FDA UDI	Class I	Active
DEL-JECT CARRIER Tip (Straight)	355029	FDA UDI	Class I	Active
Access-Tips -Package of 25	B1636	FDA UDI	Class I	Active
Comfort Fit 3.0 Magnifiers Black Clear	355861	FDA UDI	Class I	Active
Ultimate Flosser (Blue fork with White Body)	22221	FDA UDI	Class I	Active
Spandex Vertical Lip Retractor (Child)	605457	FDA UDI	Class I	Active
Mirabor-Fg (12 Burs)	355230	FDA UDI	Class I	Active
Mirasuc Aspirator	254133	FDA UDI	Class I	Active
Uni-Tip -Package of 100	B1633	FDA UDI	Class I	Active
Mirror Suction Single-Sided - Introductory Kit	254050	FDA UDI	Class I	Active
Mirror Suction Single-Sided Blue Handle with Head	254055	FDA UDI	Class I	Active
Bull Frog "Expert" Series Combo Kit Long	B11192	FDA UDI	Class I	Active
BurButler ( 25 Hole Pink Base w/Lid)	355260	FDA UDI	Class I	Active
Mirror Suction - Cleaning Brush	254067	FDA UDI	Class I	Active
Mirapost Dental Post Refills L-2	355989	FDA UDI	Class I	Active
Algilock Perforated Trays (Set/8)	101031	FDA UDI	Class I	Unknown
BurButler ( 5 Hole Orange Base w/Lid)	355252	FDA UDI	Class I	Active
Almore Microfil Instrument - Blue	96043	FDA UDI	Class I	Active

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