Identity
- Trade Name
- AdDent FDA UDI
- Generic Name
- Toluidine blue O solution IVD FDA UDI
- 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. FDA UDI
- Model / Reference
- OraBlu FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 112001 FDA UDI
- Primary DI / UDI-DI
- D8691120010 FDA UDI
- 510(k) Number
- K121282 FDA UDI
- FDA Product Code
- NXV FDA UDI
- GMDN Term
- Toluidine blue O solution IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Toluidine blue O solution IVD
AdDent by Addent, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Addent, Inc.
Sources (1)
- FDA UDI ecf634f9-3b2d-4275-b788-f7f1ff02dfd7 36 fields · synced May 30, 2026