Identity
- Trade Name
- DIAFLEX TYPE III EUDAMEDDiaFlex FDA UDI
- Generic Name
- Dental irrigation/aspiration syringe FDA UDI
- Device Name
- DIAFLEX EUDAMEDSyringe for root canal irrigation FDA UDI
- Model / Reference
- 1003-301 EUDAMEDTYPE III FDA UDI
- Description
- Syringe for root canal irrigation FDA UDI
Identifiers
- Catalog Number
- 1003-301 FDA UDI
- Primary DI / UDI-DI
- 08806383500272 EUDAMEDFDA UDI
- Basic UDI-DI
- 88063835DIS47 EUDAMED
- FDA Product Code
- EIC FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental irrigation/aspiration syringe 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: Dental irrigation/aspiration syringe
DiaFlex by DiaDent Group International — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental irrigation/aspiration syringe.
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- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- CanalPro — Coltene/Whaledent Inc. · Class I
- Henry Schein — HENRY SCHEIN, INC. · 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 bd513688-e25a-4698-8060-3bf727266af0 35 fields · synced Oct 7, 2026
- EUDAMED c35acae9-e0b1-4df0-a25f-6fec1a98ef48 61 fields · synced Jun 19, 2026