Identity
- Trade Name
- G-CAM FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- 95 Monochroma 20NBL2 FDA UDI
- Model / Reference
- GC00039 FDA UDI
- Description
- 95 Monochroma 20NBL2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08445644000689 FDA UDI
- 510(k) Number
- K220329 FDA UDI
- FDA Product Code
- EBF FDA UDIEBG FDA UDIEBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.3770 FDA UDI872.3760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental appliance fabrication material, thermoplastic
G-Cam by Graphenano Dental Sl. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental appliance fabrication material, thermoplastic.
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- Clear Advantage — ORTHO TECHNOLOGY, INC. · Class I
- BioBleach® soft — Dreve Dentamid GmbH · Class I
- AvaDent — Global Dental Science · Class II
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- Ou Nuo — Changzhou Ou Nuo Medical Equipment Co., Ltd. · Class I
Cleared under the same submission
K220329 also covers:
- G-CAM — GRAPHENANO DENTAL SL.
- G-CAM — GRAPHENANO DENTAL SL.
- G-CAM — GRAPHENANO DENTAL SL.
- G-CAM — GRAPHENANO DENTAL SL.
- G-CAM — GRAPHENANO DENTAL SL.
- G-CAM — GRAPHENANO DENTAL SL.
- G-CAM — GRAPHENANO DENTAL SL.
- G-CAM — GRAPHENANO DENTAL SL.
- G-CAM — GRAPHENANO DENTAL SL.
- G-CAM — GRAPHENANO DENTAL SL.
- G-CAM — GRAPHENANO DENTAL SL.
- G-CAM — GRAPHENANO DENTAL SL.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Graphenano Dental Sl.
Sources (1)
- FDA UDI e9c995eb-140c-4ec8-a992-89c6a047973a 35 fields · synced Jun 8, 2026