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
Mylar Foil - S/S BLUE - 7/8"	73002	FDA UDI	Class I	Active
Almore Margin Wax (purple)	42610	FDA UDI	Class I	Active
Replacment Lens 1.0 Magnifiersgen Rm Rpl. 1.0 Cl Ud	355854	FDA UDI	Class I	Active
Markley Threaded Wire .018	38018	FDA UDI	Class I	Unknown
Hager Avion Orange/Clear Lens	100923	FDA UDI	Class I	Active
Mirror Suction Single-Sided - Mini Kit	254068	FDA UDI	Class I	Active
Saliva Ejector Tubing 100 Ft. (each)	B3010	FDA UDI	Class I	Active
Del-Ject Carrier (45 Degree)	355034	FDA UDI	Class I	Active
Bull Frog "Expert" Series SS Combo Kit	B22272	FDA UDI	Class I	Active
Reso-Pac Hydrophilic Periodontal Dressing	155018	FDA UDI	Class II	Active
Pink Tong Clin Deluxe (single)	607028	FDA UDI	Class I	Active
Hydro Vac Saliva Ejector	B11138	FDA UDI	Class I	Active
Bull Frog "Expert" Series Combo Kit 110 Degree	B11212	FDA UDI	Class I	Unknown
Algilock Perforated Trays	101036	FDA UDI	Class I	Active
Jewels Silver Mirror Anti Scratch	355722	FDA UDI	Class I	Active
Ergo-Vac Valve Stem	B11173	FDA UDI	Class I	Active
UNI SYRINGE-3-WAY SYRINGE-a-dec STYLE WITH QUICKDISCONNECT FOR A/W TIPS	B10554	FDA UDI	Class I	Active
Protho Brush Deluxe - Blue (single)	607023	FDA UDI	Class I	Active
HYDRO-VAC SALIVA EJECTORWITHOUT 1/2in SWIVEL ADAPTOR	B11139	FDA UDI	Class I	Active
Bur-Tainer/Bur Cassette-Holds 7 -gray (each)	B1500BG	FDA UDI	Class I	Active
Ultra-Vac Valve Body, H.v.e.	B11155	FDA UDI	Class I	Active
FLEX H.V.E. (1/2in TUBING) 7 FT.LIGHT GRAY (EACH)	B3000	FDA UDI	Class I	Active
I-Prox L (green) Pk Of 6	630213	FDA UDI	Class I	Active
Mirabor-Fg (24 Burs)-	355232	FDA UDI	Class I	Active
Almore Bite Registration Tabs	42602	FDA UDI	Class I	Active
Hager Outbacks Gold	100700	FDA UDI	Class I	Active
Mirror Suction Double-Sided - Hose	254083	FDA UDI	Class I	Active
Clear Gasket for 8 qt. Pot	66049	FDA UDI	Class I	Active
Almore Bite Registration Sheets	42600	FDA UDI	Class I	Active
Miracastset Of 2 Model Former-Lower	203067	FDA UDI	Class I	Active
Hager Outbacks Silver Clear Lens	100710	FDA UDI	Class I	Active
Rotoprox 2mm.(box/10 Pcs) Straight/Greeninterdental Cleaning-Brush	605719	FDA UDI	Class I	Active
Mirror Suction Double-Sided Red Handle with Head	254071	FDA UDI	Class I	Unknown
Bull Frog Se Lever (gray) Pk/3for Saliva Ejector	B11122	FDA UDI	Class I	Active
Ultimate Flosser Refills	22218	FDA UDI	Class I	Active
Uni-Tip -Package of 25	B1635	FDA UDI	Class I	Active
Algilock Perforated Trays	101037	FDA UDI	Class I	Active
Uvex Genesis Black Clear Lens	355810	FDA UDI	Class I	Active
Impla Clean- Number 2	355222	FDA UDI	Class I	Active
MetaLIFT Small Burs	452231	FDA UDI	Class I	Active
Tong-Clin Deluxe- Pink- (pk-12)	607037	FDA UDI	Class I	Active
Bio-Guard Starter Pack (32 Pouches) Plus One Tip & Pour Dispenser	B2001	FDA UDI	Class I	Active
Algilock Solid Tray	101049	FDA UDI	Class I	Active
Bull Frog "Expert" Series 110 HVE	B11210	FDA UDI	Class I	Active
Soft Bitewing Flaps	656303	FDA UDI	Class I	Active
Focu-Tip No.8 (set/2) White Light Intensifying Tip	355087	FDA UDI	Class I	Active
Spandex Child	605455	FDA UDI	Class I	Unknown
Waxing Instrument #6 Black	304056	FDA UDI	Class I	Unknown
Reamers Refills S-6 (6/Set)	356029	FDA UDI	Class I	Active
Algilock Solid Tray	101006	FDA UDI	Class I	Active

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