← Back to catalogue
SoftFlow
EUDAMEDFDA UDIClass I (EU MDR)
Ref SF-YRef SF-PRef SF-SETRef SF-B
by Dentos Inc.
Identity
- Trade Name
- SoftFlow EUDAMEDFDA UDI
- Generic Name
- Orthodontic appliance relief material FDA UDI
- Device Name
- SoftFlow EUDAMED
- Model / Reference
- SF-Y EUDAMEDFDA UDISF-SET EUDAMEDFDA UDISF-P EUDAMEDFDA UDISF-B EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806145484048 EUDAMEDFDA UDI08806145484062 EUDAMEDFDA UDI08806145484024 EUDAMEDFDA UDI08806145484000 EUDAMEDFDA UDI
- Basic UDI-DI
- 88061454SF001KR EUDAMED
- Unit of Use DI
- 08806145484888 EUDAMED08806145484864 EUDAMED08806145484840 EUDAMED
- FDA Product Code
- EGD FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic appliance relief material FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6890 FDA UDI
- Market of Registration
- France EUDAMEDPoland 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
Yes
FDA UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
SoftFlow by DENTOS Inc. — 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 | 88061454SF001KR | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentos Inc.
- EUDAMED SRN
- KR-MF-000002156
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (9)
- EUDAMED 16967c31-a13e-4d93-b824-1674cce259f6 61 fields · synced Jul 27, 2026
- FDA UDI ab61753f-7dab-4e10-bfc5-3fd417f724be 32 fields · synced May 29, 2026
- FDA UDI c7cc64f8-df2e-4fef-91b5-c7da50967336 32 fields · synced May 29, 2026
- FDA UDI d6112eea-464f-48cf-bdab-5655a059376a 32 fields · synced May 29, 2026
- FDA UDI cbee3c61-8fa5-419f-abef-795698165933 32 fields · synced May 30, 2026
- EUDAMED a1801ac7-64d5-461f-99ad-24a701cc6961 61 fields · synced Jul 8, 2026
- EUDAMED 8daeaa43-84f7-4fd7-99e4-c04f1a11a73f 61 fields · synced Jul 15, 2026
- EUDAMED 10b77b09-3208-4615-b074-d1403ceaa8a5 61 fields · synced Jul 25, 2026
- EUDAMED 53ea7c96-4a1f-4022-99d4-5cd7b46f7529 61 fields · synced Jul 27, 2026