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Dia-Kondensor
EUDAMEDFDA UDIClass I (EU MDR)
Ref 551-101Model DIA-KONDENSOR #35/70
Identity
- Trade Name
- DIA-KONDENSOR EUDAMEDFDA UDIDIA-KONDENSOR #35/70 EUDAMED
- Generic Name
- Endodontic filling material condenser FDA UDI
- Device Name
- DIA-KONDENSOR EUDAMEDDIA-KONDENSOR is having both a nIckel-titanium end a stainless steel end, it can be used in any common endodontic obturation technique including warm and cold condensation. FDA UDI
- Model / Reference
- DIA-KONDENSOR #35/70 EUDAMED551-101 EUDAMED#35/70 FDA UDI
- Description
- DIA-KONDENSOR is having both a nIckel-titanium end a stainless steel end, it can be used in any common endodontic obturation technique including warm and cold condensation. FDA UDI
Identifiers
- Catalog Number
- 551-101 FDA UDI
- Primary DI / UDI-DI
- 08806383545792 EUDAMEDFDA UDI
- Basic UDI-DI
- 88063835EFMCU2 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- L15900699 DENTAL MATERIAL PROCESSING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Endodontic filling material condenser FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4130 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
Dia-Kondensor by Diadent Group International — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88063835EFMCU2 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Diadent Group International
- EUDAMED SRN
- KR-MF-000023806
- Authorised Representative
- Diadent Europe B.V. NL-AR-000012597
Sources (3)
- EUDAMED 8948ecdd-72c3-4069-980e-eed90bc3a3cf 61 fields · synced Jul 27, 2026
- FDA UDI d0a76a56-f503-4e52-a60e-3be98f3cc3e5 34 fields · synced May 29, 2026
- EUDAMED 1d707bd8-6ce4-420e-a6eb-884f2a05a296 61 fields · synced Jul 27, 2026