gudid
Primary ID: OraBlu
AdDent (UDI OraBlu)
Manufactured by ADDENT, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for AdDent - Primary ID OraBlu
Device Regulatory Overview
The AdDent (Model/Catalog Number: OraBlu) is a medical device manufactured by ADDENT, INC.. This product is indexed under FDA Product Code / Category Classification NXV within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- OraBlu
- Product Code / EMDN
- NXV
- Device Name
- The ORABLU Oral Lesion Marking System is a three component swab system intended to be used by a dentist or physician as an adjunct to traditional oral examination by incandescent light with further examination with an oral examination light manufactured by AdDent,Inc. The ORABLU Oral Lesion Marking System is used as an aid to enhance the visualization of oral mucosal irregularities by physically marking areas of oral mucosa that may warrant further investigation.
- Database Sync Date
- 2026-08-09 09:03:36
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 AdDent?
The registered manufacturer of record for AdDent is ADDENT, INC..
What is the Primary UDI-DI identifier for AdDent?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OraBlu.
What classification code is assigned to this device?
This device is registered under product classification code NXV.
Similar Classification Devices (NXV)
Other Devices by ADDENT, INC.
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