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
Twin Dento Brush (brush Only)	605901	FDA UDI	Class I	Active
Almore Microfil Instrument - Gold	96041	FDA UDI	Class I	Unknown
Bull Frog Standard	B11105	FDA UDI	Class I	Unknown
Clip-on Loupe 3 Diopter (#713)	87020	FDA UDI	Class I	Active
Algilock Solid Tray	101003	FDA UDI	Class I	Active
Hager Outbacks Patient Black Shorttemples	100709	FDA UDI	Class I	Active
Waxing Instrument #2 Green	304052	FDA UDI	Class I	Active
Comfi-Tips	15508	FDA UDI	Class I	Active
Miratray Implant Adanced	101255	FDA UDI	Class I	Active
Mirror Suction Double-Sided Red Yellow with Head	254073	FDA UDI	Class I	Active
Crown & Bridge Probe	65998	FDA UDI	Class I	Active
Mirror Suction - Handle (Blue)	254062	FDA UDI	Class I	Active
TS1 Tongue Vacuum Cleaner	630062	FDA UDI	Class I	Active
Infant -o- Brush Blue (single)	605616	FDA UDI	Class I	Active
Miracastset Of 2 Model Former-Jumbo	203069	FDA UDI	Class I	Active
I-Prox L (pink) Pk Of 6	630210	FDA UDI	Class I	Active
Waxed Floss Spool (200 Yards)	22233	FDA UDI	Class I	Active
Servicable Extended	B10116	FDA UDI	Class I	Unknown
Waxing Instrument #4 Red	304054	FDA UDI	Class I	Active
Mini Vac Saliva Ejector-Stainless Steelwithout Swivel Adaptor (10 Yr. Warranty)	B22258	FDA UDI	Class I	Active
H.v.e. Lever, Gray (3/Pk)	B11113	FDA UDI	Class I	Active
Twin Dento Box W/Brush	605902	FDA UDI	Class I	Active
Spandex Advanced Kit ( 1 Standard/ 1 Large)	605460	FDA UDI	Class I	Active
Algilock Perforated Trays	101041	FDA UDI	Class I	Unknown
Hager Jewels Feline Wraparounds Reg Fit/Clear Lens	100931	FDA UDI	Class I	Active
Hager Avions Blue/Clear Lens Slim Fit/Wraparounds	100921	FDA UDI	Class I	Active
Bull Frog "Expert" Series SS Combo Kit	B22272	FDA UDI	Class I	Unknown
Spandex Vertical Lip Retractor (Adult)	605456	FDA UDI	Class I	Active
Plast Frame	355319	FDA UDI	Class I	Active
Waxing Instrument #5 Gray	304055	FDA UDI	Class I	Unknown
Mirahold Child	605451	FDA UDI	Class I	Active
Salibag Disposable Pouch for CCD/SLB-L	656232	FDA UDI	Class I	Unknown
Bullfrog Swivel Adapter For Saliva Ejector (each) (delrin)	B11121DEL	FDA UDI	Class I	Active
Mylar Foil - D/S BLUE - 7/8"	73010	FDA UDI	Class I	Active
Mirror Suction Head (1)	254057	FDA UDI	Class I	Active
Mirapost Dental Post Refills L-4	355991	FDA UDI	Class I	Active
Bullfrog Swivel Adapter For Saliva Ejector (each) (aluminum)	B11121	FDA UDI	Class I	Active
Mirror Suction Double-Sided Red Blue with Head	254074	FDA UDI	Class I	Unknown
Spartan A401 Gray	355502	FDA UDI	Class I	Active
Markley Threaded Wire .033	38033	FDA UDI	Class I	Unknown
Mirafill (#1)/(#1)small Filling Instrument	355440	FDA UDI	Class I	Active
Mirror Suction - Cleaning Brush	254067	FDA UDI	Class I	Unknown
Waxing Kit (set Of 6)	304050	FDA UDI	Class I	Active
Impla Clean Plastic Implant Instrument Kit	355220	FDA UDI	Class I	Active
Hager Zoom Magnifiers +1.0	100912	FDA UDI	Class I	Active
H.v.e. Valve Body, Standard (each)	B11111	FDA UDI	Class I	Active
Mirahold Child	605451	FDA UDI	Class I	Unknown
Mirabor-Fg/Ca (12 Burs)-	355242	FDA UDI	Class I	Active
Uvex Blue-Astrospec	355515	FDA UDI	Class I	Active
Mirror Suction Double-Sided Red Blue with Head	254074	FDA UDI	Class I	Active

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