Identity
- Trade Name
- Tetric 100 Flow 2 Refill 1x2g A1 EUDAMEDTetric 100 Flow 2 FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Tetric EvoFlow, Evetric Flow, Tetric 100 Flow, Tetric 100 Flow 2, Tetric N-Flow, Tetric N-Flow 2, Tetric plus Flow, Choice Flow, Choice N-Flow, Tetric N-plus Flow, Tetric plus 100 Flow EUDAMEDTetric 100 Flow 2 Refill 1x2g A1 FDA UDI
- Model / Reference
- 755812WW EUDAMEDFDA UDI
- Description
- Tetric 100 Flow 2 Refill 1x2g A1 FDA UDI
Identifiers
- Catalog Number
- 755812WW FDA UDI
- Primary DI / UDI-DI
- 07615208437720 EUDAMEDFDA UDI
- Basic UDI-DI
- 76152082AFILL005JJ EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental composite resin
Tetric 100 Flow 2 Refill 1x2g A1 by Ivoclar Vivadent AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
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- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
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 | 76152082AFILL005JJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent AG
- EUDAMED SRN
- LI-MF-000000522
Sources (2)
- EUDAMED 47353e7f-0d15-44bd-a6e1-8d6ccfbfe45e 61 fields · synced Jun 18, 2026
- FDA UDI 4135608a-442d-430c-97ee-981fa8aa8d0d 34 fields · synced May 30, 2026