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
MetaLIFT Magnum Burs	452234	FDA UDI	Class I	Active
1/2 Hollenback Wax Tip (PKT)	66024	FDA UDI	Class I	Active
Mirapost Dental Posts 120 Asst. G/P6 Each Post	355999	FDA UDI	Class I	Active
Mirror Suction Double-Sided - Handle (Gray)	254082	FDA UDI	Class I	Active
Bull Frog Se Spool Only Replacement Part (each)	B11125	FDA UDI	Class I	Active
Almore Aluminum Oxide	13772	FDA UDI	Class I	Active
Serviceable Standard	B10115	FDA UDI	Class I	Unknown
Wire Clip-On Loupe (+5)	87048	FDA UDI	Class I	Active
Mirapost Dental Posts 60 Asst. G/P5 Dozen Posts	355974	FDA UDI	Class I	Active
Access-Tips -Package of 100	B1634	FDA UDI	Class I	Active
Mirror Suction Single-Sided Red Handle with Head	254052	FDA UDI	Class I	Unknown
Comfort Fit 1.5 Magnifiers Blk Clgen Rm Blk Clr	355855	FDA UDI	Class I	Active
H.v.e. Valve Body, Extended (each)	B11116	FDA UDI	Class I	Active
Bull Frog "Expert" Series 110 HVE (Stationary Head)	B11210S	FDA UDI	Class I	Active
Bull Frog Extended	B11106	FDA UDI	Class I	Active
Mirror Suction Double-Sided Red Gray with Head	254075	FDA UDI	Class I	Unknown
Uvex Genesis Blue Clear Lens	355816	FDA UDI	Class I	Active
Bull Frog Extendede Combo Kit	B11103	FDA UDI	Class I	Active
Mirabor-Ca (12 Burs)-	355234	FDA UDI	Class I	Active
Uni-Tip	B1629C	FDA UDI	Class I	Active
Uvex Orange Blockers	355499	FDA UDI	Class I	Active
Bullfrog Aluminum Terminator	B22215	FDA UDI	Class I	Active
Mirror Suction Single-Sided Red Handle with Head	254052	FDA UDI	Class I	Active
Hager Zoom Magnifiers +1.5	100913	FDA UDI	Class I	Active
Uvex Avatar Eyewear Teal Frame W/Clear Lens	356121	FDA UDI	Class I	Active
MIRAFIT WHITE POST REFILL L2, (PK/6)1.20MM x 20MM, GLASS FIBER	356045	FDA UDI	Class I	Active
Uni-Tip -Package of 3	B1629	FDA UDI	Class I	Active
Clip-on Loupe 7 Diopter (#717)	87050	FDA UDI	Class I	Active
Mirror Suction Single-Sided Yellow Handle with Head	254054	FDA UDI	Class I	Unknown
Mirror Suction Single-Sided Yellow Handle with Head	254054	FDA UDI	Class I	Active
Markley Threaded Wire .045	38045	FDA UDI	Class I	Unknown
Algilock Perforated Trays	101033	FDA UDI	Class I	Active
Mini SafeDispense	22231	FDA UDI	Class I	Active
Adaptor, Extended Swivel	B11109E	FDA UDI	Class I	Active
SafeDispense - Dual	22238	FDA UDI	Class I	Active
Surgical Tip-Stainless Steel3/16 Length (each)	B10104	FDA UDI	Class I	Active
Algilock Perforated Trays (Set/8)	101031	FDA UDI	Class I	Active
Algilock Solid Tray	101004	FDA UDI	Class I	Active
Mirapost Dental Post Refills M-1	355982	FDA UDI	Class I	Active
Waxing Instrument #3 Brown	304053	FDA UDI	Class I	Active
Saliva Ejector Tip (Gray) - Pack of 1	B10114	FDA UDI	Class I	Active
Bull Frog Extended	B11106	FDA UDI	Class I	Unknown
Algilock Perforated Trays	101034	FDA UDI	Class I	Active
Mirror Suction Double-Sided Red Gray with Head	254075	FDA UDI	Class I	Active
SafeDispense - Silver	22230	FDA UDI	Class I	Active
Serviceable 1/2 Swivel Adapter (black)	B10122	FDA UDI	Class I	Active
Mylar Foil - D/S RD/BK - 7/8"	73019	FDA UDI	Class I	Active
Mirahold Adult	605450	FDA UDI	Class I	Unknown
Mirror Suction Single-Sided Green Handle with Head	254053	FDA UDI	Class I	Active
Impla Clean- Number 3	355223	FDA UDI	Class I	Active

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