Identity
- Trade Name
- Metapex(2 Syringe) FDA UDI
- Generic Name
- Endodontic temporary cement FDA UDI
- Device Name
- Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform. 2 Syringe(2.2g) FDA UDI
- Model / Reference
- 9201 FDA UDI
- Description
- Metapex is a paste type root canal filling material. It is consist of Calcium Hydroxide with lodoform. 2 Syringe(2.2g) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806387892014 FDA UDI
- 510(k) Number
- K032603 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Endodontic temporary cement FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 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
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
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
Metapex(2 Syringe) by Meta Biomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic temporary cement.
- Vitapex — Neodental Chemical Products Co., Ltd. · Class II
- IQ Dental — IQ DENTAL SUPPLY LLC · Class II
- Vivid TempFill LC — PEARSON DENTAL SUPPLIES, INC. · Class II
- Vivid Root MTA — PEARSON DENTAL SUPPLIES, INC. · Class II
- Vitapex — Neodental Chemical Products Co., Ltd. · Class II
- Hexa — Hexa Dental · Class II
- MAARC DENTAL-Calahyd-RC — Shiva Products · Class II
- ApexCal — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class II
Cleared under the same submission
K032603 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
- Meta Biomed, Inc.
Sources (1)
- FDA UDI 01810bed-9e4a-42d4-a85b-97161af7d698 34 fields · synced May 30, 2026