Identity
- Trade Name
- DUO-PEN HEATING CONDENSER EUDAMEDDUO-PEN FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- DUO-PEN HEATING CONDENSER EUDAMEDDuo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Percha Obturators or Gutta Percha Points.) FDA UDI
- Model / Reference
- .04-40 / 4007-2070 EUDAMEDDUO-PEN HEATING CONDENSOR(04-40) FDA UDI
- Description
- Duo-Pen is an endodontic device that uses heat to cut, soften, down-pack and compact the root canal filling material(Gutta Percha Obturators or Gutta Percha Points.) FDA UDI
Identifiers
- Catalog Number
- 4007-2070 FDA UDI
- Primary DI / UDI-DI
- 08806383556989 EUDAMEDFDA UDI
- Basic UDI-DI
- 88063835HCFH EUDAMED
- FDA Product Code
- EKR FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Endodontic obturation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Moist Heat or Steam Sterilization FDA UDI
Category: Endodontic obturation system
Duo-Pen by DiaDent Group International — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endodontic obturation system.
- EndoPilot D-Pack — Schlumbohm GmbH & Co. KG · Class I
- Needle — B&L Biotech Co., Ltd. · Class I
- Needle — B&L Biotech Co., Ltd. · Class I
- B&L-Beta(W) — B&L Biotech Co., Ltd. · Class I
- Hot Testing Tip — B&L Biotech Co., Ltd. · Class I
- elements IC — META SYSTEMS CO., LTD. · Class I
- EndoPilot DownPack expansion set — Schlumbohm GmbH & Co. KG · Class I
- B&L-Alpha II(P) — B&L Biotech Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DiaDent Group International
Sources (2)
- FDA UDI d45483ef-76e6-417e-8a93-b3aeab1dfb78 35 fields · synced Jul 15, 2026
- EUDAMED d70e5f98-5ace-4bd7-a756-c85d9169c033 61 fields · synced Jul 15, 2026