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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 3 of 212
DeviceModel / ReferenceRegistriesClassStatus
Brasseler USA 5020960U0
FDA UDI
Class IActive
Brasseler USA 5014977U0
FDA UDI
Class IActive
Brasseler USA 5020584U0
FDA UDI
Class IActive
Brasseler USA 001110U0
FDA UDI
Class IActive
Brasseler USA 5025311U0
FDA UDI
N/AActive
Brasseler USA 5025100M0
FDA UDI
Class IActive
Brasseler USA 5020710U1
FDA UDI
Class IActive
Brasseler USA Surgical Power & Accessories 5004100M0
FDA UDI
Class IIActive
High Speed Burs BR5820-107-040
FDA UDI
Class IActive
Brasseler USA 004092G0
FDA UDI
Class IActive
Brasseler USA 5011723U0
FDA UDI
Class IActive
Brasseler USA 000677T0
FDA UDI
Class IActive
Brasseler USA 5030759U0
FDA UDI
Class IActive
Brasseler USA 005304SP
FDA UDI
Class IActive
Brasseler USA 5020512U0
FDA UDI
Class IActive
Brasseler USA 013744T0
FDA UDI
Class IActive
Brasseler USA 5026512U0
FDA UDI
N/AActive
Brasseler USA 011782U1
FDA UDI
Class IActive
Brasseler USA 004629U0
FDA UDI
Class IActive
Brasseler USA 5008452U0
FDA UDI
Class IIActive
Brasseler USA 5024349M0
FDA UDI
Class IActive
Brasseler USA 322514-B
FDA UDI
Class IIActive
Brasseler USA 5018326U0
FDA UDI
Class IActive
Brasseler USA 5011787U0
FDA UDI
Class IActive
Brasseler USA 019505U0
FDA UDI
Class IActive
Brasseler USA 5018288U0
FDA UDI
N/AActive
Brasseler USA 012243U0
FDA UDI
Class IActive
Brasseler USA 5028470M0
FDA UDI
Class IActive
Brasseler USA 5026536U0
FDA UDI
N/AActive
Brasseler USA 5010812U0
FDA UDI
Class IActive
Brasseler USA 5001851U0
FDA UDI
Class IActive
Brasseler USA 5028228U0
FDA UDI
N/AActive
Brasseler USA 5008661U0
FDA UDI
Class IActive
Brasseler USA 004125U0
FDA UDI
Class IActive
Brasseler USA 004843U1
FDA UDI
Class IActive
Brasseler USA 5024188U0
FDA UDI
N/AActive
Brasseler USA 004742AC
FDA UDI
Class IActive
Brasseler USA 5007773U0
FDA UDI
Class IActive
Brasseler USA 5027324U0
FDA UDI
Class IActive
Brasseler USA 004079G0
FDA UDI
Class IActive
Brasseler USA 5008385U0
FDA UDI
N/AActive
Brasseler USA 5021640U0
FDA UDI
N/AActive
Brasseler USA 5013540U0
FDA UDI
Class IActive
Brasseler USA 5026681U0
FDA UDI
Class IActive
Brasseler USA 020210U0
FDA UDI
Class IActive
Brasseler USA 001406S1
FDA UDI
Class IActive
Brasseler USA 001101U0
FDA UDI
Class IActive
Brasseler USA 209005-B
FDA UDI
Class IActive
Brasseler USA 5025077U0
FDA UDI
N/AActive
Brasseler USA 5011838U0
FDA UDI
Class IActive

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