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
Mirapost Dental Post Refills S-1	355976	FDA UDI	Class I	Active
Mirapost Dental Post Refills L-6	355993	FDA UDI	Class I	Active
Electra Waxer (110v)	66000	FDA UDI	Class I	Active
QUICK-TIPS (1000/BX) [10 packs =1000]	605222	FDA UDI	Class I	Active
Almore Margin Wax (red) 1 Lb.	42611	FDA UDI	Class I	Active
Ultra Vac	B11150	FDA UDI	Class I	Unknown
Algilock Solid Tray	101011	FDA UDI	Class I	Active
Waxing Instrument #1 Blue	304051	FDA UDI	Class I	Unknown
Anaerobic Jar Only (no Seal, Clamp, Or Lid)	12906	FDA UDI	Class I	Active
Pelotte Plus Evacuation Tip	254024	FDA UDI	Class I	Unknown
Algilock Perforated Trays	101032	FDA UDI	Class I	Unknown
I-Prox L (assorted) Pk Of 6	630216	FDA UDI	Class I	Active
Mirabor-Fg (48 Burs)-	355233	FDA UDI	Class I	Active
Endo Foam Refill - Blue	33630B	FDA UDI	Class I	Active
Algilock Solid Tray	101003	FDA UDI	Class I	Unknown
Mirafill (#2)/(#2)-Middle Filling Instrument	355441	FDA UDI	Class I	Active
Ergo Vac Combo Kit	B11180	FDA UDI	Class I	Active
Ergo-Vac Valve Head	B11172	FDA UDI	Class I	Active
Mirror Suction - Adapter (11mm)	254065	FDA UDI	Class I	Unknown
Spiral Reamer No.2 (set/3)	356031	FDA UDI	Class I	Active
Bio-Guard Starter Pack (32 Pouches)	B2002	FDA UDI	Class I	Active
Mirapost Dental Post Refills M-3	355984	FDA UDI	Class I	Active
Mirror Suction Double Sided - Cleaning Brush	254086	FDA UDI	Class I	Unknown
Mirror Suction Single-Sided - Mini Kit	254068	FDA UDI	Class I	Unknown
Markley Threaded Wire .056	38056	FDA UDI	Class I	Unknown
Bull Frog "Expert" Series Long	B11190	FDA UDI	Class I	Unknown
Bio Vacuum Tip - Short	254011	FDA UDI	Class I	Active
Salibag Disposable Pouch for CCD/SLB-L	656232	FDA UDI	Class I	Active
MIRAFIT WHITE POST REFILL L3, (PK/6)1.35MM x 20MM, GLASS FIBER	356046	FDA UDI	Class I	Active
Algilock Solid Tray	101007	FDA UDI	Class I	Active
Mirafill (#3)/(#0)-Big Filling Instrument	355442	FDA UDI	Class I	Active
Surfactant 32oz	62800	FDA UDI	Class I	Active
Uvex Spitfire (black/Tinted)	355591	FDA UDI	Class I	Active
Uni-Tip Long -Package of 25	B1637	FDA UDI	Class I	Active
Uvex Goggle Case (black W/Zipper) Eyewear Storage Case	89002	FDA UDI	Class I	Active
Salibag Disposable Pouch for CCD/SLB-LL	656233	FDA UDI	Class I	Unknown
Hager H.V.E Handpiece w/ 1/2" Swivel Tubing Adapter	B11150BN	FDA UDI	Class I	Active
Bio-Guard Tip & Pour Dispenser (each)	B2004	FDA UDI	Class I	Active
Mirror Suction Double-Sided Red Handle with Head	254071	FDA UDI	Class I	Active
BurButler ( 10 Hole White Base w/Lid)	355253	FDA UDI	Class I	Active
Rotoprox Mini Flat 14mm 50 Pk	605792	FDA UDI	Class I	Active
Hager Outbacks Blue	100706	FDA UDI	Class I	Active
Bull Frog Hve Adapter For A-Dec Hve (each)	B11101	FDA UDI	Class I	Active
Bull Frog Saliva Ejector Combo Kit	B11118	FDA UDI	Class I	Unknown
Saliva Ejector Tubing 7 Ft. (each)	B3008	FDA UDI	Class I	Active
Trollfoil D/S Red (500)	72074	FDA UDI	Class I	Unknown
Infant Toothbrush- Pink (pk-12)	605610	FDA UDI	Class I	Active
Protho Brush-Translucent-Pink- (pk-12)	607017	FDA UDI	Class I	Active
Waxing Instrument #5 Gray	304055	FDA UDI	Class I	Active
H.V.E. 1/2in WHITE DELRIN SWIVEL ADAPTOR	B11109KN	FDA UDI	Class I	Active

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