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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 6 of 212
DeviceModel / ReferenceRegistriesClassStatus
Brasseler USA 5009093M0
FDA UDI
Class IActive
Brasseler USA 000164T0
FDA UDI
Class IActive
Brasseler USA 5021441U0
FDA UDI
N/AActive
Brasseler USA 5000546U0
FDA UDI
Class IActive
Brasseler USA 5009234U0
FDA UDI
Class IActive
Brasseler USA 005041U0
FDA UDI
Class IActive
Brasseler USA 020689U1
FDA UDI
Class IActive
Brasseler USA 004424U1
FDA UDI
Class IActive
Brasseler USA 004397U0
FDA UDI
Class IActive
Brasseler USA 5014442M0
FDA UDI
Class IIActive
Non-Br2000 Large Bone Blades BR11-2325
FDA UDI
Class IActive
Brasseler USA 5029948U0
FDA UDI
N/AActive
Brasseler USA 5023686U0
FDA UDI
Class IActive
Brasseler USA 5023992U0
FDA UDI
Class IActive
Brasseler USA 001299U0
FDA UDI
Class IActive
Brasseler USA 5026445U0
FDA UDI
N/AActive
Brasseler USA Surgical Power & Accessories 5004128M0
FDA UDI
Class IIActive
Brasseler USA 021097U4
FDA UDI
Class IActive
Brasseler USA 011655U0
FDA UDI
Class IActive
Brasseler USA 018301U0
FDA UDI
Class IActive
Br2000 Blades BR1-2590-47
FDA UDI
Class IActive
Brasseler USA 005041SP
FDA UDI
Class IActive
Brasseler USA 004871U0
FDA UDI
Class IActive
Brasseler USA 5009233U0
FDA UDI
Class IActive
Brasseler USA 005159U1
FDA UDI
Class IActive
Brasseler USA 5027294U0
FDA UDI
Class IActive
Brasseler USA 5030829U0
FDA UDI
Class IActive
Brasseler USA 5026617U0
FDA UDI
Class IActive
Brasseler USA 5027368U0
FDA UDI
N/AActive
Brasseler USA 5025591U0
FDA UDI
N/AActive
Brasseler USA 5021318U0
FDA UDI
Class IActive
Brasseler USA 5026795T0
FDA UDI
Class IActive
Brasseler USA 000083U0
FDA UDI
Class IActive
Brasseler USA AR1-25-70-094-SAG 5P
FDA UDI
Class IActive
Brasseler USA 033138-B
FDA UDI
Class IActive
Brasseler USA 5031389U0
FDA UDI
Class IActive
Brasseler USA 5013086M0
FDA UDI
Class IIActive
Brasseler USA 5026828U0
FDA UDI
N/AActive
Brasseler USA 5009259M0
FDA UDI
Class IActive
Brasseler USA 004838U4
FDA UDI
Class IActive
Brasseler USA 5012005M0
FDA UDI
Class IUnknown
Brasseler USA 5028087U0
FDA UDI
Class IActive
Brasseler USA 5022866U0
FDA UDI
N/AActive
Brasseler USA 5023873S1
FDA UDI
Class IActive
Brasseler USA 5023939U0
FDA UDI
N/AActive
Brasseler USA 5023864U0
FDA UDI
Class IActive
Brasseler USA 017271U1
FDA UDI
Class IActive
Brasseler USA 5013816U0
FDA UDI
N/AActive
Brasseler USA 5025248U0
FDA UDI
N/AActive
Brasseler USA 5023275U0
FDA UDI
Class IActive

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