Question 1

What types of medical devices does Schlumbohm GmbH & Co. KG manufacture?

Accepted Answer

Schlumbohm GmbH & Co. KG specializes in dental medical devices. Their portfolio includes dental power tool systems like line-powered handpieces for precision procedures, endodontic devices such as apex locators and obturation systems for root canal treatments, synthetic gutta-percha for sealing root canals, and ultrasonic dental scaling/debridement systems for periodontal care. These devices are designed to support procedures in endodontics and oral hygiene.

Question 2

Where is Schlumbohm GmbH & Co. KG based?

Accepted Answer

Schlumbohm GmbH & Co. KG is based in the United States. While the company’s headquarters location is not specified, their devices are regulated under U.S. medical device standards, including the FDA’s Unique Device Identifier (UDI) system.

Question 3

Which regulatory registries list Schlumbohm GmbH & Co. KG’s devices?

Accepted Answer

Schlumbohm GmbH & Co. KG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations by assigning a unique identifier to each device, helping track and monitor their distribution and use.

Question 4

How are Schlumbohm GmbH & Co. KG’s devices classified under U.S. regulations?

Accepted Answer

Schlumbohm GmbH & Co. KG’s devices fall under different classification categories in the U.S. regulatory system: Class I (generally low-risk devices), Class II (devices requiring special controls to ensure safety and effectiveness), and unclassified (U) devices, which may not yet have a formal classification or are exempt from premarket submission requirements. Classification depends on factors like intended use, risk level, and regulatory pathway.

Device	Model / Reference	Registries	Class	Status
EndoPilot D-Pack	v03	FDA UDI	Class I	Active
EndoPilot Cap for lip-contact	EDP2	FDA UDI	U	Active
EndoPilot power supply	US	FDA UDI	Class I	Active
EndoPilot Motor	EDP2	FDA UDI	Class I	Active
EndoPilot wireless-footswitch, twin	bluetooth	FDA UDI	Class I	Active
EndoPIlot wireless-footswitch, single	bluetooth	FDA UDI	Class I	Active
EndoPilot² expansion DownPack²	v01	FDA UDI	Class I	Active
EndoPilot Apex measuring cable with plug	EDP2	FDA UDI	U	Active
EndoPilot cable for file clamp	EDP2	FDA UDI	U	Active
EndoPilot apex cable set	EDP2	FDA UDI	U	Active
EndoPilot Obtura set	v01	FDA UDI	Class I	Active
EndoPilot DownPack expansion set	v00	FDA UDI	Class I	Active
EndoPilot D-Pack² handpiece	v04	FDA UDI	Class I	Active
Extension set ultrasonic for EndoPilot	v01	FDA UDI	Class II	Active
EndoPilot contra-angle	1:1	FDA UDI	Class I	Active
EndoPilot retainer for apexcable	EDP2	FDA UDI	Class I	Active
EndoPilot Lip-clip	EDP2	FDA UDI	U	Active
EndoPilot File clamp	EDP2	FDA UDI	U	Active
EndoPilot Control Box, Komet	EDP2	FDA UDI	Class I	Active
EndoPilot Komet	comfort	FDA UDI	U	Active

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