Identity
- Trade Name
- OralID FDA UDI
- Generic Name
- Oral lesion examination light FDA UDI
- Device Name
- OralID is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer. FDA UDI
- Model / Reference
- FS-11 FDA UDI
- Description
- OralID is intended to be used by a dentist or physician as an adjunct to an oral examination to aid in visualization of oral mucosal abnormalities, such as oral cancer and pre-cancer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00370275123163 FDA UDI
- 510(k) Number
- K123169 FDA UDI
- FDA Product Code
- NXV FDA UDI
- GMDN Term
- Oral lesion examination light 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oral lesion examination light
OralID by Forward Science Technologies Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123169 also covers:
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
- Forward Science Technologies Llc
Sources (1)
- FDA UDI 0632d2a9-8e31-46a7-9f2b-ca42f1e165f9 35 fields · synced Jun 8, 2026