Identity
- Trade Name
- DIA-PEN FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- Dia-Pen supports warm vertical compaction and has proven to be effectice as an integral part of downpack obturator system. FDA UDI
- Model / Reference
- DIA-PEN,HANDPIECE FDA UDI
- Description
- Dia-Pen supports warm vertical compaction and has proven to be effectice as an integral part of downpack obturator system. FDA UDI
Identifiers
- Catalog Number
- 4002-1010 FDA UDI
- Primary DI / UDI-DI
- 08806383538954 FDA UDI
- FDA Product Code
- EKR FDA UDI
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic obturation system
Dia-Pen by DiaDent Group International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endodontic obturation system.
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- elements IC — META SYSTEMS CO., LTD. · Class I
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- B&L-Alpha II(P) — B&L Biotech Co., Ltd. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- DiaDent Group International
Sources (1)
- FDA UDI c67b434f-2c45-44c8-a1d7-d7aa8058a534 35 fields · synced Jun 8, 2026