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 S.E.	B11130	FDA UDI	Class I	Active
Ergo Vac Combo Kit (Stationary Head)	B11180S	FDA UDI	Class I	Active
Miratray Implant Adanced	101252	FDA UDI	Class I	Active
Quick-Tips	605220	FDA UDI	Class I	Active
Miratray Implant Adanced	101251	FDA UDI	Class I	Active
Hager Zoom Magnifiers +2.0rx-500c2.0	100914	FDA UDI	Class I	Active
Ergo Vac Combo Kit (Stationary Head)	B11180S	FDA UDI	Class I	Unknown
Hydro Vac Saliva Ejector Combo Kit	B11140	FDA UDI	Class I	Active
Waxing Instrument #1 Blue	304051	FDA UDI	Class I	Active
Mirror Suction Double-Sided - Handle (Gray)	254082	FDA UDI	Class I	Unknown
Focu-Tip No.12 (set/2) White Light Intensifying Tip	355089	FDA UDI	Class I	Active
Mirror Suction Double-Sided Red Green with Head	254072	FDA UDI	Class I	Unknown
Hager Jewels Tortoise Shell	355717	FDA UDI	Class I	Active
Mini Vac Saliva Ejector Combo Kit	B22259	FDA UDI	Class I	Unknown
Access-Tips -Package of 100	B1634	FDA UDI	Class I	Unknown
Mirapost Dental Post Refills L-1	355988	FDA UDI	Class I	Active
Mirror Suction Double-Sided -Mini Kit	254070	FDA UDI	Class I	Active
Serviceable Saliva Ejector Tip - Pack of 1	B10113	FDA UDI	Class I	Unknown
Saliva Ejector Tip (Gray) - Pack of 3	B10108	FDA UDI	Class I	Active
Almore Microfil Instrument - Green	96042	FDA UDI	Class I	Unknown
Bull Frog Standard Combo Kit	B11104	FDA UDI	Class I	Active
Hager H.V.E Handpiece w/ 1/2" Swivel Tubing Adapter	B11150BN	FDA UDI	Class I	Unknown
Hager Outbacks Pink	100704	FDA UDI	Class I	Active
Hager Outbacks Green	100707	FDA UDI	Class I	Active
Algilock Perforated Tray	101047	FDA UDI	Class I	Unknown
Mirror Suction Head (6)	254058	FDA UDI	Class I	Active
Rotoprox Mini Tapered 50pk	605793	FDA UDI	Class I	Active
Spandex Vertical Lip Retractor (Child)	605457	FDA UDI	Class I	Active
Zahn Picks-Box Of 100 Individually Wrapped	605637	FDA UDI	Class I	Active
Mirabor-Hp (18 Burs)-	355239	FDA UDI	Class I	Active
Miratray Implant Adanced	101250	FDA UDI	Class I	Active
Algilock Solid Tray (set/10)	101001	FDA UDI	Class I	Unknown
Mirror Suction Double-Sided - Handle (Yellow)	254080	FDA UDI	Class I	Active
MetaLIFT Regular Removal Instrument Replacement Part	452222	FDA UDI	Class I	Active
Almore Aluminum Oxide	13773	FDA UDI	Class I	Active
MIRATRAY ADHESIVE SPRAY7.5 fl oz (225ml) CFC FREE	554210	FDA UDI	Class I	Active
Mirapost Dental Post Refills M-4	355985	FDA UDI	Class I	Active
P.K.T. # 2 Medium Tip	66013	FDA UDI	Class I	Active
Access-Tips -Package of 25	B1636	FDA UDI	Class I	Unknown
Mirapost Dental Posts 240 Asst. G/P20 Dozen Posts	355975	FDA UDI	Class I	Active
Lip-Ex	605212	FDA UDI	Class I	Active
Bite Block	605210	FDA UDI	Class I	Active
MetaLIFT Medium Burs	452232	FDA UDI	Class I	Active
DEL-JECT CARRIER Inside Piston	355027	FDA UDI	Class I	Active
CROWN CLICK DELUXE Replacement Tip # 2	452207	FDA UDI	Class I	Active
DEL-JECT CARRIER Tip (110 Degree)	355042	FDA UDI	Class I	Active
Bullfrog Expert Series Saliva Ejector W/O Swivel 100% Stainless Steel Body & Tip	B22271	FDA UDI	Class I	Active
Spring Clip-On Loupe (+3)	87022	FDA UDI	Class I	Active
Clip-on Loupe 5 Diopter (#715)	87021	FDA UDI	Class I	Active
Econo Tips-Pink (1000/Pk)micro Applicators [10 Boxes= 1000]	605164	FDA UDI	Class I	Active

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