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
Bull Frog "Expert" Series Combo Kit Long	B11192	FDA UDI	Class I	Unknown
Algilock Non-Perforated Trays (Set/2)	101030	FDA UDI	Class I	Active
Mirror Suction - Handle (Yellow)	254061	FDA UDI	Class I	Active
Econo Tips-Green (100/Pk)micro Applicators	605151	FDA UDI	Class I	Active
Mylar Foil - D/S GREEN - 7/8"	72015	FDA UDI	Class I	Active
Impla Clean- Number 3	355223	FDA UDI	Class I	Unknown
Mirafit Reamer L3 (3), 1.5mm Diameter	356049	FDA UDI	Class I	Active
Econo Tips-Orange (1000/Pk)micro Applicators [10 Boxes = 1000]	605162	FDA UDI	Class I	Active
Uni-Tip -Package of 5	BOA124P1000	FDA UDI	Class I	Unknown
Algilock Perforated Trays	101039	FDA UDI	Class I	Unknown
Spear Tip For Green Microfil	96046	FDA UDI	Class I	Active
Hager Otg Sleeksover The Glass	100900	FDA UDI	Class I	Active
H.V.E. 1/2 in SWIVEL TUBING ADAPTER	B11109	FDA UDI	Class I	Active
Spandex Adult	605454	FDA UDI	Class I	Unknown
Bull Frog Saliva Ejector	B11119	FDA UDI	Class I	Unknown
Uni-Tip -Package of 5	BOA124P1000	FDA UDI	Class I	Active
Mirahold Child	605451	FDA UDI	Class I	Active
Vapor Ii Ultra Lite/Black/Tinted11150916	355506	FDA UDI	Class I	Active
Mirror Suction Double-Sided - Handle (Yellow)	254080	FDA UDI	Class I	Unknown
Algilock Solid Tray	101042	FDA UDI	Class I	Active
I-Prox L (bordeaux) Pk Of 6	630215	FDA UDI	Class I	Active
Mirror Suction Double-Sided - Handle (Green)	254079	FDA UDI	Class I	Active
Mini Waxer W/3 Tips - 110V	65999	FDA UDI	Class I	Active
Algilock Solid Tray	101008	FDA UDI	Class I	Unknown
MetaLIFT Key Wrench Replacement Part	452224	FDA UDI	Class I	Active
Almore Inlay Wax (purple) 1 Lb.	42614	FDA UDI	Class I	Active
H.v.e. Valve Spool (each)	B11112	FDA UDI	Class I	Active
Hager Avion Neon Green/Clear Lens	100924	FDA UDI	Class I	Active
Mirror Suction - Handle (Green)	254060	FDA UDI	Class I	Unknown
MIRACOLD PLUS SPRAY CAN (OZONE-SAFE)GREEN LABEL 6.8 fl. oz. (200 ml)	554213	FDA UDI	Class I	Active
DEL-JECT CARRIER (Straight)	355037	FDA UDI	Class I	Active
FLEX H.V.E. (1/2in TUBING) 100 FT.LIGHT GRAY (EACH)	B3002	FDA UDI	Class I	Active
Mirror Suction - Handle (Gray)	254063	FDA UDI	Class I	Active
Swe-Flex	254150	FDA UDI	Class I	Active
Markley Threaded Wire .040	38040	FDA UDI	Class I	Unknown
Mirror Suction - Handle (Green)	254060	FDA UDI	Class I	Active
Ultra Vac Combo Kit	B11152	FDA UDI	Class I	Active
Algilock Solid Tray	101002	FDA UDI	Class I	Unknown
Bullfrog "expert" Series-Saliva Ejector Valve Body Only (stainless Steel)	B11400	FDA UDI	Class I	Active
Mirabor-Hp (48 Burs)	355241	FDA UDI	Class I	Active
DEL-JECT CARRIER Tip (90 Degree)	355028	FDA UDI	Class I	Active
Almore Inlay Wax (green) 2 Oz.	42607	FDA UDI	Class I	Active
P.K.T. # 3 Small Tip	66014	FDA UDI	Class I	Active
Mirror Suction Double Sided - Cleaning Brush	254086	FDA UDI	Class I	Active
Algilock Perforated Tray	101046	FDA UDI	Class I	Active
Implant Tweezers (titanium)	304451T	FDA UDI	Class I	Active
Bf Expert Series Hve Valve Spool W/Lever (stainless Steel)	B11301	FDA UDI	Class I	Active
CROWN CLICK DELUXE Replacement Tip # 1	452206	FDA UDI	Class I	Active
Almore Inlay Wax (blue) 2 Oz.	42606	FDA UDI	Class I	Active
Bull Frog Standard Combo Kit	B11104	FDA UDI	Class I	Unknown

Hager Worldwide, Inc.

About

What Hager Worldwide, Inc. makes

Frequently asked questions

Information

Catalogue (703)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities