Identity
- Trade Name
- AxioPro ART FDA UDI
- Generic Name
- Calcium hydroxide dental cement FDA UDI
- Model / Reference
- 25002 Intro Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- D161250020 FDA UDI
- FDA Product Code
- EJK FDA UDI
- GMDN Term
- Calcium hydroxide dental cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3250 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Calcium hydroxide dental cement
AxioPro ART by Axiodent Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Calcium hydroxide dental cement.
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Calcimol LC — VOCO GmbH · Class II
- ADSEAL — Meta Biomed Co., Ltd. · Class IIa
- Cerafill RCS — PREVEST DENPRO LIMITED · Class II
- Endoseal — PREVEST DENPRO LIMITED · Class II
- Cerafill Putty — PREVEST DENPRO LIMITED · Class IIa
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Calplus — PREVEST DENPRO LIMITED · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Axiodent Inc.
Sources (1)
- FDA UDI 95d0895e-1d3e-43a4-868c-c5c46b10abeb 32 fields · synced May 30, 2026