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
Interproximal Abrasive Contact	13870	FDA UDI	Class I	Active
Almore Powdered Wax (9 Gm)	42700	FDA UDI	Class I	Active
Bull Frog Saliva Ejector	B11119	FDA UDI	Class I	Active
Bull Frog Expert Series Hve-Handpiece-Short-W/O Swivel Adaptor	B11196	FDA UDI	Class I	Active
Mylar Foil - D/S RED - 7/8"	72016	FDA UDI	Class I	Active
Almore Powdered Wax (1 Lb)	42701	FDA UDI	Class I	Active
Mirror Suction - Handle (Red)	254059	FDA UDI	Class I	Unknown
Protho Brush- Translucent Blue (pk-24)	607016	FDA UDI	Class I	Active
UVEX GENESIS MMT - 50% Tint	356130	FDA UDI	Class I	Active
Algilock Perforated Trays	101038	FDA UDI	Class I	Active
Bull Frog "Expert" Series Medium	B11200	FDA UDI	Class I	Active
SafeDispense - White	22236	FDA UDI	Class I	Active
Bull Frog "Expert" Series 110 HVE	B11210	FDA UDI	Class I	Unknown
Mylar Foil - S/S GREEN - 7/8"	72007	FDA UDI	Class I	Active
Salibag Disposable Pouch for CCD/SLB-LL	656233	FDA UDI	Class I	Active
Mirror Suction - Handle (Blue)	254062	FDA UDI	Class I	Unknown
Miratray Implant Adanced	101253	FDA UDI	Class I	Active
Mirror Suction Double Sided - Adapter (11mm)	254084	FDA UDI	Class I	Active
Almore Margin Wax (red) 2 Oz.	42608	FDA UDI	Class I	Active
P.K.T. # 7 Spoon Tip	66015	FDA UDI	Class I	Active
Hager Outbacks Black	100702	FDA UDI	Class I	Active
Markley Threaded Wire .022	38022	FDA UDI	Class I	Unknown
Almore Inlay Wax (green) 1 Lb.	42612	FDA UDI	Class I	Active
Compo-Blitz Assorted (box Of 6 Thick/6 Normal Felt Wheels)	503322	FDA UDI	Class I	Active
Hager Outbacks Purple	100705	FDA UDI	Class I	Active
Uni-Tip -Package of 25	B1635	FDA UDI	Class I	Unknown
Bull Frog "Expert" Series Combo Kit Medium	B11202	FDA UDI	Class I	Active
Algilock Perforated Trays	101039	FDA UDI	Class I	Active
Almore Base Plate Wax (red)	42603	FDA UDI	Class I	Active
Cross Key G/P (male) Set/2	356028	FDA UDI	Class I	Active
Mirror Suction Single-Sided Blue Handle with Head	254055	FDA UDI	Class I	Unknown
Ergo Vac	B11171	FDA UDI	Class I	Unknown
Biohazard Shipping Pouch	B4605	FDA UDI	Class I	Active
Algilock Solid Tray (set/10)	101001	FDA UDI	Class I	Active
Infant -o- Brush Pink (single)	605615	FDA UDI	Class I	Active
Uvex Stealth Otg Goggle (navy Body/Clear Lens) Eyewear	89000	FDA UDI	Class I	Active
Almore Bite Registration Tabs	42602	FDA UDI	Class I	Unknown
Algilock Solid Tray	101009	FDA UDI	Class I	Unknown
DEL-JECT CARRIER (110 Degree)	355040	FDA UDI	Class I	Active
Reso-Pac Hydrophilic Periodontal Dressing	155020	FDA UDI	Class II	Active
Minitray Crown & Bridge Impression Trays	101102	FDA UDI	Class I	Active
Mirror Suction Single-Sided Gray Handle with Head	254055	FDA UDI	Class I	Unknown
Super Quick-Tips (1000/Bx)10/100 Packs = 1000 Bx	605227	FDA UDI	Class I	Active
Waxing Instrument #2 Green	304052	FDA UDI	Class I	Unknown
CROWN CLICK DELUXE Replacement Tip # 3	452208	FDA UDI	Class I	Active
Algilock Solid Tray	101048	FDA UDI	Class I	Active
MIRROR SUCTION Double Sided HEAD (1)	254076	FDA UDI	Class I	Unknown
Mirapost Dental Post Refills M-2	355983	FDA UDI	Class I	Active
Mirapost Dental Post Refills S-4	355979	FDA UDI	Class I	Active
Pelotte Plus Evacuation Tip	254024	FDA UDI	Class I	Active

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