gudid
Primary ID: JB-0014
One Plus (UDI JB-0014)
Manufactured by Hexa Dental
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for One Plus - Primary ID JB-0014
Device Regulatory Overview
The One Plus (Model/Catalog Number: JB-0014) is a medical device manufactured by Hexa Dental. This product is indexed under FDA Product Code / Category Classification ELW within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- JB-0014
- Product Code / EMDN
- ELW
- Device Name
- ONE Bite Registration Material 50ml, 100 Cartridges BULK, Fast Set
- Database Sync Date
- 2026-08-09 09:08:43
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of One Plus?
The registered manufacturer of record for One Plus is Hexa Dental.
What is the Primary UDI-DI identifier for One Plus?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is JB-0014.
What classification code is assigned to this device?
This device is registered under product classification code ELW.
Similar Classification Devices (ELW)
Other Devices by Hexa Dental
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