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Ena HRI ®
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref EFFUD2Model Light Curing Composite 6b1
by Micerium Spa
Identity
- Trade Name
- Ena HRI ® FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Name: Light Curing Composite Model: Flow EUDAMEDEna HRi Flow UD2 1g Light Curing Composite FDA UDI
- Model / Reference
- EFFUD2 EUDAMEDFDA UDILight Curing Composite 6b1 EUDAMED
- Description
- Ena HRi Flow UD2 1g Light Curing Composite FDA UDI
Identifiers
- Catalog Number
- EFFUD2 FDA UDI
- Primary DI / UDI-DI
- EMICEFFUD21 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1AE6B1FV 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 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 — 1 Gram FDA UDI
Category: Dental composite resin
Ena HRI ® by Micerium Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- 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
Cleared under the same submission
K062906 also covers:
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micerium Spa
Sources (2)
- FDA UDI 4a3c2596-da01-46b4-8086-35df23a6fefd 37 fields · synced Jun 19, 2026
- EUDAMED 69aa6609-b35a-42a8-bb50-4de76bb0ee6f 61 fields · synced Jun 19, 2026