← Back to catalogue
Enamel Plus Hri "flow"
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref CHRFUD3,5Model DentineRef CHRTUD3Model Light Curing Composite 6aRef COSVITBD3,5Ref ERUD3,5Ref CRBD0,5Ref CHRTBD3,5Ref CHRBD3,5Ref TEMPUD3,5Model TEMPRef TEMP4-UD3,5Ref COSVITBD0,5Ref TEMP1-UD3,5Ref CHRTUD3,5Ref CHRTUD0,5Ref EHRTBD3,5Ref EHRBD0,5Ref EHRUD0,5Ref EHRUD3,5Ref CRBD3,5Ref EHRTUD3,5Ref CHRUD3,5-20Ref CRUD0,5Ref CHRUD3,5Ref CHFUD3,5-20
Identity
- Trade Name
- ENAMEL PLUS HRI "FLOW" EUDAMEDEna HRI ® FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Light Curing Composite EUDAMEDEna HRi Dentin UD0,5 5g Light Curing Composite FDA UDIEna HRi Bio Dentine BD0,5 5g Light Curing Composite FDA UDIEna HRi Bio Dentine BD3,5 12 tips x 0.3 g each Light Curing Composite FDA UDIEna HRi Dentin UD3,5 5g Light Curing Composite FDA UDIEna HRi Dentin UD3,5 2.5g Light Curing Composite FDA UDIEna HRi Dentin UD3,5 12 tips x 0.3 g each Light Curing Composite FDA UDI
- Model / Reference
- Dentine EUDAMEDCHRFUD3,5 EUDAMEDEHRUD0,5 EUDAMEDFDA UDIEHRBD0,5 EUDAMEDFDA UDIEHRTBD3,5 EUDAMEDFDA UDIEHRUD3,5 EUDAMEDFDA UDIERUD3,5 EUDAMEDFDA UDIEHRTUD3,5 EUDAMEDFDA UDILight Curing Composite 6a EUDAMEDCHRTUD3 EUDAMEDCOSVITBD3,5 EUDAMEDCRBD0,5 EUDAMEDCHRTBD3,5 EUDAMEDCHRBD3,5 EUDAMEDTEMP EUDAMEDTEMPUD3,5 EUDAMEDTEMP4-UD3,5 EUDAMEDCOSVITBD0,5 EUDAMEDTEMP1-UD3,5 EUDAMEDCHRTUD3,5 EUDAMEDCHRTUD0,5 EUDAMEDCRBD3,5 EUDAMEDCHRUD3,5-20 EUDAMEDCRUD0,5 EUDAMEDCHRUD3,5 EUDAMEDCHFUD3,5-20 EUDAMED
- Description
- Ena HRi Dentin UD0,5 5g Light Curing Composite FDA UDIEna HRi Bio Dentine BD0,5 5g Light Curing Composite FDA UDIEna HRi Bio Dentine BD3,5 12 tips x 0.3 g each Light Curing Composite FDA UDIEna HRi Dentin UD3,5 5g Light Curing Composite FDA UDIEna HRi Dentin UD3,5 2.5g Light Curing Composite FDA UDIEna HRi Dentin UD3,5 12 tips x 0.3 g each Light Curing Composite FDA UDI
Identifiers
- Catalog Number
- EHRUD0,5 FDA UDIEHRBD0,5 FDA UDIEHRTBD3,5 FDA UDIEHRUD3,5 FDA UDIERUD3,5 FDA UDIEHRTUD3,5 FDA UDI
- Primary DI / UDI-DI
- +EMICCHRFUD350E EUDAMEDEMICEHRUD051 EUDAMEDFDA UDIEMICEHRBD051 EUDAMEDFDA UDIEMICEHRTBD351 EUDAMEDFDA UDIEMICEHRUD351 EUDAMEDFDA UDIEMICERUD351 EUDAMEDFDA UDIEMICEHRTUD351 EUDAMEDFDA UDIEMICCHRTUD31 EUDAMEDEMICCOSVITBD351 EUDAMEDEMICCRBD051 EUDAMEDEMICCHRTBD351 EUDAMEDEMICCHRBD351 EUDAMEDEMICTEMPUD351 EUDAMEDEMICTEMP4UD351 EUDAMEDEMICCOSVITBD051 EUDAMEDEMICTEMP1UD351 EUDAMEDEMICCHRTUD351 EUDAMEDEMICCHRTUD051 EUDAMEDEMICCRBD351 EUDAMEDEMICCHRUD35201 EUDAMEDEMICCRUD051 EUDAMEDEMICCHRUD351 EUDAMEDEMICCHFUD35201 EUDAMED
- Basic UDI-DI
- ++EMICestikaBB EUDAMED++EMICFAM1AEUX EUDAMED++EMICFAM439 EUDAMED
- 510(k) Number
- K062906 FDA UDI
- 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
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDIFDA 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
No
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
Dimensions & Sizes
- Size
- Weight — 5 Gram FDA UDIWeight — 3.6 Gram FDA UDIWeight — 2.5 Gram FDA UDI
Category: Dental composite resin
Enamel Plus Hri "flow" by Micerium S.p.A. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- SimpliShade — KERR CORPORATION · Class II
- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
- CLEARFIL MAJESTY ES Flow Universal Low (U) — Kuraray Noritake Dental Inc. Kurashiki · Class IIa
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 | ++EMICestikaBB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micerium S.p.A.
- EUDAMED SRN
- IT-MF-000010187
Sources (51)
- EUDAMED e92ff8aa-a4fb-4102-8792-33b44940b6f7 61 fields · synced Sep 17, 2026
- FDA UDI 097789b7-9dcc-4f66-91c8-2f7eae15d85d 37 fields · synced May 30, 2026
- FDA UDI f5206c24-7273-4270-87a0-06bd5dcaac27 37 fields · synced May 30, 2026
- FDA UDI 5d063dc6-43b7-4f2e-ae7d-d7452feb92f7 37 fields · synced May 30, 2026
- FDA UDI 48648ca1-0c0a-45d7-af86-853f7c475986 37 fields · synced May 30, 2026
- FDA UDI 9613b1e8-8e6f-4b8a-b8a7-da5133822e28 37 fields · synced May 30, 2026
- FDA UDI abe88877-5c5f-4758-bd7c-3bb934ba8468 37 fields · synced May 30, 2026
- EUDAMED e92ff8aa-a4fb-4102-8792-33b44940b6f7-1 61 fields · synced Jun 10, 2026
- EUDAMED 46619986-ba01-4d76-b002-795bdb46b8be 61 fields · synced Jun 14, 2026
- EUDAMED a7d19ace-866d-4a79-913a-edae6ff77f00-1 61 fields · synced Jun 20, 2026
- EUDAMED a7d19ace-866d-4a79-913a-edae6ff77f00-2 61 fields · synced Jun 20, 2026
- EUDAMED fa9d38d3-7b72-4004-9620-f941bf114828-1 61 fields · synced Jun 20, 2026
- EUDAMED fa9d38d3-7b72-4004-9620-f941bf114828-2 61 fields · synced Jun 20, 2026
- EUDAMED 55d03fa3-62d7-4f91-858f-b9ed96a2eef0-1 61 fields · synced Jul 9, 2026
- EUDAMED 55d03fa3-62d7-4f91-858f-b9ed96a2eef0-2 61 fields · synced Jul 9, 2026
- EUDAMED ee99147d-3651-4e6d-be9c-89dd3b9c0fa5-1 61 fields · synced Jul 9, 2026
- EUDAMED ee99147d-3651-4e6d-be9c-89dd3b9c0fa5-2 61 fields · synced Jul 9, 2026
- EUDAMED d8ba4320-db21-46b1-a917-18dbdefa3f4a-1 61 fields · synced Jul 10, 2026
- EUDAMED d8ba4320-db21-46b1-a917-18dbdefa3f4a-2 61 fields · synced Jul 10, 2026
- EUDAMED dfc12929-23ce-4741-88da-e4cc869afcea-1 61 fields · synced Jul 11, 2026
- EUDAMED dfc12929-23ce-4741-88da-e4cc869afcea-2 61 fields · synced Jul 11, 2026
- EUDAMED fd7389dd-07c5-4ac7-b708-36bd4b639e98-1 61 fields · synced Jul 12, 2026
- EUDAMED fd7389dd-07c5-4ac7-b708-36bd4b639e98-2 61 fields · synced Jul 12, 2026
- EUDAMED 5a822ea2-8641-47c3-b274-b03923b2efb3-1 61 fields · synced Jul 16, 2026
- EUDAMED 5a822ea2-8641-47c3-b274-b03923b2efb3-2 61 fields · synced Jul 16, 2026
- EUDAMED dafb8354-d87c-4922-b49b-0e9994b8ce87-1 61 fields · synced Jul 18, 2026
- EUDAMED dafb8354-d87c-4922-b49b-0e9994b8ce87-2 61 fields · synced Jul 18, 2026
- EUDAMED 89f6d8a1-e7cd-4e8f-a8d0-0a536984e903-1 61 fields · synced Jul 18, 2026
- EUDAMED 89f6d8a1-e7cd-4e8f-a8d0-0a536984e903-2 61 fields · synced Jul 18, 2026
- EUDAMED 7d725fec-ce7e-45da-8b4f-e38b3b768e34-1 61 fields · synced Jul 20, 2026
- EUDAMED 7d725fec-ce7e-45da-8b4f-e38b3b768e34-2 61 fields · synced Jul 20, 2026
- EUDAMED 0417e874-6fba-4c2a-91b7-9a2813d11be9-1 61 fields · synced Jul 21, 2026
- EUDAMED 0417e874-6fba-4c2a-91b7-9a2813d11be9-2 61 fields · synced Jul 21, 2026
- EUDAMED 1834a8b0-8c1c-43cc-a9a7-d6cdcc99d917-1 61 fields · synced Jul 21, 2026
- EUDAMED 1834a8b0-8c1c-43cc-a9a7-d6cdcc99d917-2 61 fields · synced Jul 21, 2026
- EUDAMED 59037fe9-745a-4fb1-91f3-997357af9a5c-1 61 fields · synced Jul 24, 2026
- EUDAMED 59037fe9-745a-4fb1-91f3-997357af9a5c-2 61 fields · synced Jul 24, 2026
- EUDAMED 49d27a89-e333-49b7-876b-3514e152553b-1 61 fields · synced Jul 25, 2026
- EUDAMED 49d27a89-e333-49b7-876b-3514e152553b-2 61 fields · synced Jul 25, 2026
- EUDAMED 6816b1cd-ab5a-42ca-ab15-3696c9ad78c8-1 61 fields · synced Jul 26, 2026
- EUDAMED 6816b1cd-ab5a-42ca-ab15-3696c9ad78c8-2 61 fields · synced Jul 26, 2026
- EUDAMED 09da1989-243e-4f3f-be0d-aa856d26f778-1 61 fields · synced Jul 29, 2026
- EUDAMED 09da1989-243e-4f3f-be0d-aa856d26f778-2 61 fields · synced Jul 29, 2026
- EUDAMED 9cbe4fa4-ae4a-44ee-9e69-dc0f0ac469c8-1 61 fields · synced Jul 29, 2026
- EUDAMED 9cbe4fa4-ae4a-44ee-9e69-dc0f0ac469c8-2 61 fields · synced Jul 29, 2026
- EUDAMED 59bb5c67-a9f2-40f7-b2ce-e5fca48376ee-1 61 fields · synced Jul 31, 2026
- EUDAMED 59bb5c67-a9f2-40f7-b2ce-e5fca48376ee-2 61 fields · synced Jul 31, 2026
- EUDAMED bbe8a33a-42f3-40ce-985a-27a4fb8f1e14-1 61 fields · synced Sep 17, 2026
- EUDAMED bbe8a33a-42f3-40ce-985a-27a4fb8f1e14-2 61 fields · synced Sep 17, 2026
- EUDAMED ecc66d3d-41fe-4e1d-97ca-9b53b6dfcb24-1 61 fields · synced Sep 17, 2026
- EUDAMED ecc66d3d-41fe-4e1d-97ca-9b53b6dfcb24-2 61 fields · synced Sep 17, 2026