Identity
- Trade Name
- DUO-GUN GP OBTURATION TIP 25G EUDAMEDDUO-GUN FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- DUO-GUN GP OBTURATION TIP EUDAMEDDuo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable vertical injection of softened Gutta Percha through the disposable obturation tip into the root canal. FDA UDI
- Model / Reference
- 4007-2121 EUDAMEDDUO-GUN GP Obturation Tip(25G, 4ea) FDA UDI
- Description
- Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable vertical injection of softened Gutta Percha through the disposable obturation tip into the root canal. FDA UDI
Identifiers
- Catalog Number
- 4007-2121 FDA UDI
- Primary DI / UDI-DI
- 08806383557269 EUDAMEDFDA UDI
- Basic UDI-DI
- 88063835GOT5A 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
No
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-Gun 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.
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- 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 1cb1e2ca-3cfd-4cc2-8695-e981891be0a2 35 fields · synced Aug 2, 2026
- EUDAMED 785b6265-d928-4133-bba0-104095980a3f 61 fields · synced Aug 2, 2026