Identity
- Trade Name
- Vitapex FDA UDI
- Generic Name
- Endodontic temporary cement FDA UDI
- Model / Reference
- Tips Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560128312530 FDA UDI
- 510(k) Number
- K973667 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
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: Endodontic temporary cement
Vitapex by Neodental Chemical Products Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic temporary cement.
- Metapex Plus 0.8 — Meta Biomed, Inc. · Class II
- 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
- Metapaste Plus — Meta Biomed, Inc. · Class II
- Hexa — Hexa Dental · Class II
Cleared under the same submission
K973667 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Neodental Chemical Products Co., Ltd.
Sources (1)
- FDA UDI 96881c23-59cc-4794-8f26-dc7bc5db9bba 35 fields · synced May 31, 2026