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PRECISION DENTAL PRODUCTS, LLC

US

Last updated September 17, 2026

What PRECISION DENTAL PRODUCTS, LLC makes

Precision Dental Products, LLC manufactures dental diagnostic devices, including facebow attachments and bite registration rims. Their primary product, the OneBite Evolution, is designed for capturing precise occlusal records and mounting facebows in orthodontic and dental laboratory workflows.

The company’s products are classified as Class I medical devices under FDA regulations and are listed 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 Precision Dental Products, LLC manufacture?

Precision Dental Products, LLC specializes in dental diagnostic devices, specifically facebow attachments and bite registration rims. These tools are primarily used in orthodontics and dental laboratories to capture precise occlusal records and assist in mounting facebows for treatment planning.

Where is Precision Dental Products, LLC based?

The company is headquartered in the United States. This location aligns with its focus on manufacturing and distributing dental diagnostic tools tailored to US and global dental professionals.

Which regulatory registries list devices manufactured by Precision Dental Products, LLC?

Devices from Precision Dental Products, LLC are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized devices, including the OneBite Evolution, which is designed for capturing occlusal records.

How are devices from Precision Dental Products, LLC classified under FDA regulations?

The company’s devices, such as the OneBite Evolution, are classified as Class I medical devices. This classification is typically assigned to low-risk products where general controls are sufficient to ensure safety and effectiveness, as determined by FDA criteria.

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

Information

Country
US
Address
13925 Maple Hollow Cir, Draper, UT, 84020
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
3009161287
DUNS Number
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Catalogue (101)

Page 3 of 3
DeviceModel / ReferenceRegistriesClassStatus
OneBite Evolution OBEV0104
FDA UDI
Class IActive

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