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Sign in to claim this brandPeter 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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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- —
- DUNS Number
- 082080136
Catalogue (10554)
Page 5 of 212| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Brasseler USA | 001225T0 | FDA UDI | Class I | Active |
| Brasseler USA | 5009089M0 | FDA UDI | Class I | Active |
| Xp-4d | 5031738U0 | FDA UDI | Class I | Active |
| Brasseler USA | 011734U3 | FDA UDI | Class I | Active |
| Brasseler USA | 322519-B | FDA UDI | Class II | Active |
| Brasseler USA | 5028098U0 | FDA UDI | Class I | Active |
| Brasseler USA | 267000-B | FDA UDI | Class II | Active |
| Brasseler USA | 322507-B | FDA UDI | Class II | Active |
| Brasseler USA | 5028392U0 | FDA UDI | Class I | Active |
| Brasseler USA | 001101U7 | FDA UDI | Class I | Active |
| Brasseler USA | 5004223M1 | FDA UDI | Class II | Active |
| Brasseler USA | 014816U1 | FDA UDI | Class I | Active |
| Brasseler USA | 004211U0 | FDA UDI | Class I | Active |
| Brasseler USA | 5007898U4 | FDA UDI | Class II | Active |
| Brasseler USA | 000544U0 | FDA UDI | Class I | Active |
| Brasseler USA | 5008610U0 | FDA UDI | N/A | Active |
| Brasseler USA | 001240U0 | FDA UDI | Class I | Active |
| Brasseler USA | 000079U0 | FDA UDI | Class I | Active |
| Brasseler USA | 000022S0 | FDA UDI | Class I | Active |
| Brasseler USA | 004818U1 | FDA UDI | Class I | Active |
| Brasseler USA | 015225U0 | FDA UDI | Class I | Active |
| Brasseler USA | 004210U4 | FDA UDI | Class I | Active |
| Brasseler USA | 004743U0 | FDA UDI | Class I | Active |
| Brasseler USA | 5026087U0 | FDA UDI | Class I | Active |
| Brasseler USA | 5024017U0 | FDA UDI | N/A | Active |
| Brasseler USA | 5027507EU | FDA UDI | Class I | Active |
| Brasseler USA | 5027577U0 | FDA UDI | N/A | Active |
| Brasseler USA | 012639U0 | FDA UDI | Class I | Active |
| Brasseler USA | 004437U1 | FDA UDI | Class I | Active |
| Brasseler USA | 5015518U0 | FDA UDI | Class I | Active |
| Brasseler USA | 5027947U0 | FDA UDI | N/A | Active |
| Brasseler USA | 5024347U0 | FDA UDI | N/A | Active |
| Brasseler USA | 033126-B | FDA UDI | Class I | Active |
| Brasseler USA | 005005U4 | FDA UDI | Class I | Active |
| Brasseler USA | 5008972U0 | FDA UDI | Class I | Active |
| Brasseler USA | 017349U0 | FDA UDI | Class I | Active |
| Brasseler USA | 005464U0 | FDA UDI | Class I | Active |
| Brasseler USA | 000682U5 | FDA UDI | Class I | Active |
| Brasseler USA | 013159U1 | FDA UDI | Class I | Active |
| Brasseler USA | 000089U0 | FDA UDI | Class I | Active |
| Brasseler USA | 001103T0 | FDA UDI | Class I | Active |
| Brasseler USA | 000294U0 | FDA UDI | Class I | Active |
| High Speed Burs | BR5820-110-030C | FDA UDI | Class I | Active |
| Brasseler USA | 5023200U0 | FDA UDI | Class I | Active |
| Brasseler USA | 5024191U0 | FDA UDI | N/A | Active |
| Brasseler USA | 5008659U0 | FDA UDI | N/A | Active |
| Brasseler USA | 5001831U0 | FDA UDI | Class I | Active |
| Brasseler USA | 004848U1 | FDA UDI | Class I | Active |
| Non-Br2000 Large Bone Blades | BR2108-115 | FDA UDI | Class I | Active |
| Standard Burs | 03-C0905 | FDA UDI | Class I | Active |
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