Identity
- Trade Name
- Hexa FDA UDI
- Generic Name
- Dental implant kit FDA UDI
- Device Name
- Hexa Semi Permanent Implant Cement FDA UDI
- Model / Reference
- HIC-0001 FDA UDI
- Description
- Hexa Semi Permanent Implant Cement FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850057092134 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dental implant kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant kit
Hexa by Hexa Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant kit.
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- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
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
- Hexa Dental
Sources (1)
- FDA UDI 72dfb83e-ac6c-49ca-b767-697a935aebb3 33 fields · synced Jun 8, 2026