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
Mirror Suction Double-Sided - Handle (Green)	254079	FDA UDI	Class I	Unknown
Infant Toothrbrush- Blue- (pk-12)	605612	FDA UDI	Class I	Active
Mirabor-Hp (24 Burs)	355240	FDA UDI	Class I	Active
Waxing Instrument #3 Brown	304053	FDA UDI	Class I	Unknown
Mirapost Dental Post Refills L-5	355992	FDA UDI	Class I	Active
MetaLIFT Replacement Handle	452221	FDA UDI	Class I	Active
Markley Threaded Wire .025	38025	FDA UDI	Class I	Unknown
Mirror Suction Double-Sided - Intro Kit	254069	FDA UDI	Class I	Active
Hydro-Vac Spool (each)	B11136	FDA UDI	Class I	Active
Econo Tips-Green (1000/Pk)micro Applicators [10 Boxes=1000]	605161	FDA UDI	Class I	Active
MetaLIFT Regular Burs	452233	FDA UDI	Class I	Active
Mirafit White - Starter Kit (18)assorted	356059	FDA UDI	Class I	Active
Mini Vac Saliva Ejector Combo Kit	B22259	FDA UDI	Class I	Active
Almore Microfil Instrument - Green	96042	FDA UDI	Class I	Active
Trollfoil D/S Red (100)	72073	FDA UDI	Class I	Active
Plast Frame	355319	FDA UDI	Class I	Unknown
Mirror Suction Head (1)	254057	FDA UDI	Class I	Unknown
Zahn Pick Soft +	605638	FDA UDI	Class I	Active
Mirabor-Hp (12 Burs)-	355238	FDA UDI	Class I	Active
Clip-on Loupe 4 Diopter (#714)	87019	FDA UDI	Class I	Active
Bull Frog Saliva Ejector Combo Kit	B11118	FDA UDI	Class I	Active
Duration	B1620	FDA UDI	Class I	Active
Hager/Wyman Crown Holder/Remover	304025	FDA UDI	Class I	Active
Mirror Suction Double-Sided - Handle (Red)	254078	FDA UDI	Class I	Unknown
Mini Vac Saliva Ejector	B22257	FDA UDI	Class I	Active
Clip-on Loupe10 Diopter(#710)	87051	FDA UDI	Class I	Active
Mirapost Dental Post Refills Xl-4	355994	FDA UDI	Class I	Active
Super Quick-Tips (100/Bx)	605226	FDA UDI	Class I	Active
Genesis X2 Replacement Lenses	355829	FDA UDI	Class I	Active
Endo Ring (Ring Only)	33628	FDA UDI	Class I	Active
Hollow Key G/P (female) Set/2	356027	FDA UDI	Class I	Active
Algilock Perforated Trays	101033	FDA UDI	Class I	Unknown
Mirapost Dental Post Refills S-5	355980	FDA UDI	Class I	Active
Algilock Solid Tray	101006	FDA UDI	Class I	Unknown
Comfort Fit 2.0 Magnifiers Black Clear	355857	FDA UDI	Class I	Active
Impla Clean- Number 2	355222	FDA UDI	Class I	Unknown
Duration	B1621	FDA UDI	Class I	Active
Mirror Suction - Hose	254064	FDA UDI	Class I	Unknown
Saliva Ejector Tip (Gray) - Pack of 10	B10105	FDA UDI	Class I	Active
Serviceable Hve Std. Hp. Wo/Swivel (each)	B10121	FDA UDI	Class I	Active
Mirror Suction Double-Sided - Handle (Red)	254078	FDA UDI	Class I	Active
Mirror Suction Double-Sided - Handle (Blue)	254081	FDA UDI	Class I	Unknown
Mirabor-Ca (18 Burs)	355235	FDA UDI	Class I	Active
Plast Frame	355319	FDA UDI	Class I	Active
Serviceable Saliva Ejector	B10112	FDA UDI	Class I	Unknown
Almore Bite Registration Sheets	42600	FDA UDI	Class I	Unknown
H.v.e. O-Ring (6/Pk)	B11114	FDA UDI	Class I	Active
Bull Frog Expert Series Hve-Handpiece--long-- W/O Swivel	B11191	FDA UDI	Class I	Active
Madam Butterfly Silk 3/4" Red	72003	FDA UDI	Class I	Active
I-Prox L (yellow) Pk Of 6	630211	FDA UDI	Class I	Active

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