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Sign in to claim this brandGebr. Brasseler GmbH & Co. KG
US
Last updated September 17, 2026
Part of Gebr. Brasseler GmbH & Co. KG
What Gebr. Brasseler GmbH & Co. KG makes
The company manufactures reusable and single-use dental and orthopaedic cutting instruments, including diamond and carbide dental burs, orthopaedic burs, surgical sagittal saw blades, and intraoperative positioning pins. Their portfolio also includes dental abrasive points and orthopaedic guide pins, designed for precision in surgical and dental procedures.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates with a base in the United States, adhering to regulatory requirements for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Gebr. Brasseler GmbH & Co. KG primarily manufacture?
Gebr. Brasseler GmbH & Co. KG specializes in dental and orthopaedic cutting instruments. Their portfolio includes reusable and single-use products like diamond and carbide dental burs, orthopaedic burs, surgical sagittal saw blades (both reusable and single-use), intraoperative positioning pins, and dental abrasive points. These tools are designed for precision in surgical and dental procedures, ensuring reliability in clinical settings.
Where is Gebr. Brasseler GmbH & Co. KG based, and how does this affect its regulatory compliance?
Gebr. Brasseler GmbH & Co. KG is based in the United States. As a U.S.-based manufacturer, the company must comply with FDA regulations governing medical devices. Their products are listed in the FDA’s Unique Device Identifier (UDI) database, which helps ensure traceability and regulatory oversight for devices marketed in the U.S. Compliance with FDA requirements is essential for maintaining market access and meeting safety standards.
Which regulatory registries or databases list Gebr. Brasseler GmbH & Co. KG’s devices?
Gebr. Brasseler GmbH & Co. KG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling better tracking, transparency, and regulatory compliance. This listing helps healthcare providers, regulators, and other stakeholders verify the identity of the devices in use.
How are Gebr. Brasseler GmbH & Co. KG’s devices classified under FDA regulations?
Gebr. Brasseler GmbH & Co. KG’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and clinical impact, as determined by FDA guidelines.
What distinguishes Gebr. Brasseler GmbH & Co. KG’s reusable and single-use devices?
Gebr. Brasseler GmbH & Co. KG produces both reusable and single-use devices to cater to different clinical needs and preferences. Reusable instruments, like their diamond dental burs or carbide dental burs, are designed for sterilization and repeated use, offering cost efficiency for facilities with robust reprocessing protocols. Single-use devices, such as their orthopaedic intraoperative positioning pins or certain surgical saw blades, eliminate the need for sterilization, reducing infection risks and streamlining workflows for procedures where sterility is critical.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 317409001
Catalogue (5812)
Page 3 of 117| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| KOMET Surgical Saw Blade | KMS1913.01S..M2 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | 8881.314.012.A2 | FDA UDI | Class I | Active |
| KOMET Abrasive Instruments | 94023F.204.030.A2 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | 859.314.014.A2 | FDA UDI | Class I | Active |
| KOMET Dental Tungsten Carbide Burs | H1.204.014.A2 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | 847KR.314.018.A2 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | 6888.314.012.A2 | FDA UDI | Class I | Active |
| KOMET Surgical Saw Blade | KM5023.108..M0 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | 847KRXC.314.018.A1 | FDA UDI | Class I | Active |
| KOMET Dental Tungsten Carbide Burs | H135F.314.014.A2 | FDA UDI | Class I | Active |
| KOMET Dental Tungsten Carbide Burs | H379VG.312.023.A2 | FDA UDI | Class I | Active |
| KOMET Surgical Bur | NS0913.009..K2 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | 6801.314.018.AU | FDA UDI | Class I | Active |
| KOMET Dental Steel Burs | 1.204.014.A2 | FDA UDI | Class I | Active |
| KOMET Surgical Bur | ND0144.009..M0 | FDA UDI | Class I | Active |
| KOMET K-Wire | KW002.152.009.K4 | FDA UDI | Class II | Active |
| KOMET Dental Steel Burs | 1.205.023.A2 | FDA UDI | Class I | Active |
| KOMET Surgical Saw Blade | KMG1313.M62..K2 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | S6856XL.314.021.A2 | FDA UDI | Class I | Active |
| KOMET Dental Tungsten Carbide Burs | H135UF.314.014.A2 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | 830L.314.010.A2 | FDA UDI | Class I | Active |
| Guide Pin | 2024-0616 | FDA UDI | Class II | Active |
| KOMET Surgical Saw Blade | KM51915. DS..K2 | FDA UDI | Class I | Active |
| Reciprocating saw blade | 351-91-06 | FDA UDI | Class I | Active |
| KOMET Dental Tungsten Carbide Burs | H2.314.014.A6 | FDA UDI | Class I | Active |
| KOMET Surgical Bur | NC0195.012..K2 | FDA UDI | Class I | Active |
| KOMET Surgical Saw Blade | KMS1013.M00..M2 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | 859EF.314.014.A2 | FDA UDI | Class I | Active |
| KOMET Surgical Bur | NS0903.016..A2 | FDA UDI | Class I | Active |
| KOMET Dental Tungsten Carbide Burs | H2.314.006.A6 | FDA UDI | Class I | Active |
| KOMET Surgical Saw Blade | KM33.212..K2 | FDA UDI | Class I | Active |
| KOMET Surgical Saw Blade | EVO2510.16B..K2 | FDA UDI | Class I | Active |
| KOMET Surgical Saw Blade | KM73.471..M0 | FDA UDI | Class I | Active |
| Guide Pin | HTS-4P-2038A | FDA UDI | Class II | Active |
| KOMET Surgical Bur | NS2207.026..K2 | FDA UDI | Class I | Active |
| KOMET Dental Tungsten Carbide Burs | H021RS.314.010.AU | FDA UDI | Class I | Active |
| KOMET Surgical Bur | NC0101.004..K2 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | DM10.314.009.A2 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | 6860.314.014.A2 | FDA UDI | Class I | Active |
| KOMET Dental Diamond Instruments | T5837KR.314.016.A2 | FDA UDI | Class I | Active |
| KOMET Surgical Saw Blade | KM327R. AC..M2 | FDA UDI | Class I | Active |
| Steinmann Pins, K-Wire, smooth | SP004.228.016.K4 | FDA UDI | Class II | Active |
| Shannon Recta X-Large, quick coupling | P65-105-3020-S | FDA UDI | Class I | Active |
| KOMET Root Canal Files | PRQ6L31.204.020.G1 | FDA UDI | Class I | Active |
| KOMET Surgical Saw Blade | KMS2510.S81..M2 | FDA UDI | Class I | Active |
| KOMET Surgical Bur | H33R.316.016.G1 | FDA UDI | Class I | Active |
| KOMET Surgical Bur | NS0155.006..K2 | FDA UDI | Class I | Active |
| KOMET Dental Tungsten Carbide Burs | H390F.314.016.A2 | FDA UDI | Class I | Active |
| Diamond Instruments | E845KRC.314.016.DA | FDA UDI | Class I | Active |
| Diamond Instruments | E805M.314.012.DA | FDA UDI | Class I | Active |
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