Identity
- Trade Name
- ApexCal FDA UDI
- Generic Name
- Endodontic temporary cement FDA UDI
- Device Name
- ApexCal Refill 2x2.5 g FDA UDI
- Model / Reference
- 595915AN FDA UDI
- Description
- ApexCal Refill 2x2.5 g FDA UDI
Identifiers
- Catalog Number
- 595915AN FDA UDI
- Primary DI / UDI-DI
- 07615208008661 FDA UDI
- FDA Product Code
- EJK FDA UDI
- GMDN Term
- Endodontic temporary 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endodontic temporary cement
ApexCal by Ivoclar Vivadent Aktiengesellschaft — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic temporary cement.
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- Metapex(1 Syringe) — Meta Biomed, Inc. · Class II
- IQ Dental — IQ DENTAL SUPPLY LLC · Class II
- Vivid TempFill LC — PEARSON DENTAL SUPPLIES, INC. · Class II
- Metapex(2 Syringe) — Meta Biomed, Inc. · Class II
- Vivid Root MTA — PEARSON DENTAL SUPPLIES, INC. · Class II
- Vitapex — Neodental Chemical Products Co., Ltd. · 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
- Ivoclar Vivadent Aktiengesellschaft
Sources (1)
- FDA UDI f2fe16b3-0dc7-42f5-b579-60e2abbe9800 34 fields · synced May 30, 2026