Question 1

What types of medical devices does Hager & Meisinger Gesellschaft mit beschränkter Haftung manufacture?

Accepted Answer

Hager & Meisinger produces a range of dental and orthopaedic devices. Their portfolio includes two-piece screw endosteal dental implants, permanent preformed suprastructures for dental prostheses, and cementable abutment screws. They also manufacture reusable dental surgical kits, manual non-rotary instrument handles, orthopaedic bone screws, reusable steel dental burs, and periotomes. Some products focus on bone management during dental implant procedures, while others are designed as reusable surgical tools for dental and maxillofacial applications.

Question 2

Where is Hager & Meisinger Gesellschaft mit beschränkter Haftung based?

Accepted Answer

The company is based in the United States. While the legal structure suggests a German origin (Gesellschaft mit beschränkter Haftung), its primary operations and regulatory compliance align with U.S. medical device standards.

Question 3

Are Hager & Meisinger’s devices listed in any regulatory registries?

Accepted Answer

Yes, some of the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing helps track and identify specific medical devices under U.S. regulatory oversight, ensuring traceability and compliance with FDA requirements.

Question 4

How are Hager & Meisinger’s devices classified under regulatory frameworks?

Accepted Answer

The company’s devices fall into two primary regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require less stringent regulatory controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and regulatory guidelines.

Question 5

What is the purpose of the reusable dental surgical kits and manual instruments produced by Hager & Meisinger?

Accepted Answer

The reusable dental surgical kits and manual non-rotary instrument handles are designed for use in dental and maxillofacial procedures. These tools are engineered to enhance precision, durability, and ease of use during surgeries like implant placements or bone management. Their reusable nature aligns with cost-effective and sustainable clinical practices, provided they meet strict sterilization and maintenance protocols.

Device	Model / Reference	Registries	Class	Status
Oktagon®	38135	FDA UDI	Class I	Active
Oktagon®	24010	FDA UDI	Class I	Active
OCTAGON BL RC Abutment, 0°, Ø 5.0 mm L 6.0 mm, GH 3.0 mm, cementable basic screw	5022108	FDA UDI	Class II	Active
Bone Management	MSS12 10	FDA UDI	Class II	Active
Bone Management	CTR00	FDA UDI	Class I	Active
infinity OCTAGON	503312	FDA UDI	Class II	Unknown
infinity OCTAGON Bone Level Taper Dental Implant	BLT504812	FDA UDI	Class II	Unknown
Oktagon®	22137	FDA UDI	Class I	Active
Bone Management	SKR01	FDA UDI	Class I	Active
OKTAGON Dental Implant BL NC	22011	FDA UDI	Class II	Active
Oktagon®	23020	FDA UDI	Class I	Active
myplant two Implant System	PSA01	FDA UDI	Class II	Active
Oktagon®	22113	FDA UDI	Class I	Active
Bone Management	MI193	FDA UDI	Class I	Active
OKTAGON BL RC Basic screw also suiting for CAD/CAM	22122	FDA UDI	Class II	Active
Oktagon	38180	FDA UDI	Class I	Active
OKTAGON BL RC Healing abutment, conical Ø 6.5 mm GH 6.0 mm	22095	FDA UDI	Class II	Active
OKTAGON TL RP Cover screw large GH 1.5 mm	31155	FDA UDI	Class II	Active
infinity OCTAGON BL RC Healing abutment, conical Ø 5.0mm GH 6.0 mm	5022092	FDA UDI	Class II	Unknown
OKTAGON Dental Implant BLT RC	24002	FDA UDI	Class II	Active
Bone Management	BRIBA	FDA UDI	Class I	Active
Oktagon®	24024	FDA UDI	Class I	Active
OKTAGON BL RC ALLIGATOR Abutment GH 3.0 mm	22126	FDA UDI	Class II	Active
OKTAGON Dental Implant TL	31147	FDA UDI	Class II	Active
infinity OCTAGON	503310BL	FDA UDI	Class II	Unknown
Oktagon®	23018	FDA UDI	Class I	Active
Bone Management	38271	FDA UDI	Class I	Active
myplant two Implant System	PAB04	FDA UDI	Class II	Active
Bone Management	DSZ21	FDA UDI	Class I	Active
OKTAGON BL NC Healing abutment, conical Ø3.6 mm GH 2.0 mm	22017	FDA UDI	Class II	Active
OKTAGON Dental Implant TL RP	31153	FDA UDI	Class II	Active
Bone Management	833L018	FDA UDI	Class I	Active
OCTAGON Infinity TL WP Abutment angled, 15° B H 5.5 mm, cementable	5093737	FDA UDI	Class II	Unknown
infinity OCTAGON BL NC Healing abutment, conical Ø3.6 mm GH 3.5 mm	5022018	FDA UDI	Class II	Unknown
infinity OCTAGON TL RP Healing abutment GH 4.5 mm	5035751	FDA UDI	Class II	Unknown
OKTAGON TL RP ALLIGATOR Abutment GH 1.0 mm	98001	FDA UDI	Class II	Active
OKTAGON BL RC ALLIGATOR Abutment GH 1.0 mm	22124	FDA UDI	Class II	Active
Bone Management	MI183	FDA UDI	Class I	Active
OCTAGON BL NC Abutment 0° Ø 3.5 mm, L 5.5 mm GH 2.0 mm, cementable basic screw 2	5022028	FDA UDI	Class II	Active
OCTAGON BL RC Abutment, 0°, Ø 6.5 mm L 6.0 mm, GH 1.0 mm, cementable basic screw	5022109	FDA UDI	Class II	Active
Bone Management	CTRPL	FDA UDI	Class I	Active
OKTAGON BL NC ALLIGATOR Abutment GH 5.0 mm	22039	FDA UDI	Class II	Active
OKTAGON Dental Implant BL NC	22010	FDA UDI	Class II	Active
Bone Management	MSS10 6	FDA UDI	Class II	Active
Oktagon®	24015	FDA UDI	Class I	Active
Bone Management	BTRBA	FDA UDI	Class I	Active
infinity OCTAGON Bone Level Taper Dental Implant	BLT503312	FDA UDI	Class II	Unknown
Tac, dental	MTAB0	FDA UDI	Class II	Active
Oktagon®	64543	FDA UDI	Class I	Active
Oktagon®	24014	FDA UDI	Class I	Active

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