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Peter Brasseler Holdings, LLC

US

Last updated May 23, 2026

What Peter Brasseler Holdings, LLC makes

Peter Brasseler Holdings, LLC manufactures dental and orthopaedic cutting instruments, including single-use and reusable diamond and carbide burs for tooth preparation, oscillating surgical saw blades for precision cutting, and endodontic files and rasps for root canal procedures. Their portfolio also includes reusable dental abrasive points and non-bioabsorbable orthopaedic bone pins for surgical fixation.

The company’s devices are regulated under FDA’s Class I and Class II classifications, with some listed as unclassified (U), and are included in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

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 Peter Brasseler Holdings, LLC primarily manufacture?

Peter Brasseler Holdings, LLC specializes in dental and orthopaedic cutting instruments. Their portfolio includes single-use and reusable diamond and carbide dental burs for tooth preparation, oscillating surgical saw blades for precise bone or tissue cutting, and endodontic files/rasps (both single-use and reusable) for root canal treatments. They also produce reusable dental abrasive points and non-bioabsorbable orthopaedic bone pins used in surgical fixation.

Where is Peter Brasseler Holdings, LLC based, and how does that affect its regulatory oversight?

Peter Brasseler Holdings, LLC is based in the United States, which means its devices fall under FDA jurisdiction. The FDA classifies their products as Class I (generally low-risk), Class II (requiring special controls), or unclassified (U), depending on the device’s risk level and intended use. This classification determines the regulatory pathway for authorization.

Are Peter Brasseler Holdings, LLC’s devices listed in any regulatory registries, and why does this matter?

Yes, their devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing ensures traceability and transparency in the supply chain, helping healthcare providers verify product authenticity, compliance, and recall status. It also supports post-market surveillance and regulatory tracking for devices authorized under FDA pathways.

How are Peter Brasseler Holdings, LLC’s devices categorized by the FDA, and what does that mean for their use?

The FDA categorizes Peter Brasseler Holdings, LLC’s devices as Class I (low-risk, often exempt from premarket review), Class II (requires performance standards or special controls), or unclassified (U, typically higher-risk devices needing premarket submission). This classification ensures appropriate oversight based on the device’s risk profile, with Class II and U devices requiring more rigorous authorization processes to confirm safety and effectiveness before market entry.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
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LinkedIn
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Facebook
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Email
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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
082080136

Catalogue (10554)

Page 1 of 212
DeviceModel / ReferenceRegistriesClassStatus
Brasseler USA 013745U5
FDA UDI
Class IActive
Brasseler USA 000401U0
FDA UDI
Class IActive
Brasseler USA 5001878U0
FDA UDI
Class IActive
Brasseler USA Surgical Power & Accessories 5004144M0
FDA UDI
Class IIActive
Brasseler USA 5026810U0
FDA UDI
N/AActive
Brasseler USA 5008485U0
FDA UDI
N/AActive
Brasseler USA 004847AC
FDA UDI
Class IActive
Br2000 Blades BR1-3165-39F
FDA UDI
Class IActive
Brasseler USA 5028473M0
FDA UDI
Class IActive
Brasseler USA 5025777U0
FDA UDI
N/AActive
Brasseler USA AR1-21-90-127-SAG 5P
FDA UDI
Class IActive
Brasseler USA 5023516U0
FDA UDI
Class IActive
Brasseler USA 5011002U0
FDA UDI
Class IIActive
Brasseler USA 5020019U0
FDA UDI
N/AActive
High Speed Burs BR5820-110-040C
FDA UDI
Class IActive
Brasseler USA 5028386M0
FDA UDI
Class IActive
Brasseler USA 5018589U1
FDA UDI
N/AActive
Brasseler USA 5027244U0
FDA UDI
Class IActive
Brasseler USA 5025353U0
FDA UDI
N/AActive
Brasseler USA 5026552U0
FDA UDI
UActive
Brasseler USA 5020550U0
FDA UDI
Class IActive
Brasseler USA 5022709G0
FDA UDI
Class IActive
Brasseler USA 5025900U0
FDA UDI
Class IActive
Brasseler USA 004471U2
FDA UDI
Class IActive
Brasseler USA 5026816G0
FDA UDI
Class IIActive
Brasseler USA 005310U0
FDA UDI
Class IActive
Brasseler USA 004478U1
FDA UDI
Class IActive
Brasseler USA 5027718G0
FDA UDI
Class IActive
Brasseler USA 5028700U0
FDA UDI
N/AActive
Brasseler USA 5023897U0
FDA UDI
N/AActive
Brasseler USA 5022825U0
FDA UDI
N/AActive
Brasseler USA 5025966U0
FDA UDI
Class IActive
Brasseler USA 5023039U0
FDA UDI
N/AActive
Brasseler USA 5020945U0
FDA UDI
Class IActive
Brasseler USA 004162U3
FDA UDI
Class IActive
Brasseler USA 021504U0
FDA UDI
Class IActive
Brasseler USA 5028038U0
FDA UDI
N/AActive
Brasseler USA 5022670M0
FDA UDI
Class IActive
Brasseler USA 5028597U0
FDA UDI
Class IActive
Brasseler USA 5022981U0
FDA UDI
N/AActive
Brasseler USA 016035U2
FDA UDI
Class IActive
Brasseler USA 014873U0
FDA UDI
Class IActive
Brasseler USA 5026484U0
FDA UDI
N/AActive
Brasseler USA 5028484U0
FDA UDI
Class IActive
Brasseler USA 5023153U0
FDA UDI
Class IIActive
Brasseler USA 5008551U1
FDA UDI
Class IActive
Br2000 Blades BR1-19100-54
FDA UDI
Class IActive
Brasseler USA 5023371U0
FDA UDI
Class IActive
Brasseler USA 5026415U0
FDA UDI
N/AActive
Brasseler USA 5000714U0
FDA UDI
Class IActive

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