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Ena HRI ®
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref EIE414Model intra-extra oral latex elasticsRef EREF2Model Light Curing Composite 6a
by Micerium Spa
Identity
- Trade Name
- Ena HRI ® FDA UDIELASTOOSAS FDA UDI
- Generic Name
- Dental composite resin FDA UDIOrthodontic retainer FDA UDI
- Device Name
- Italia intra-extra oral latex elastics / intra-extra oral latex elastics EUDAMEDEna HRi Enamel Function EF2 2.5g Light Curing Composite FDA UDIELASTOOSAS Italia Intraoral Latex Elastics 5000 pcs 1/4" - 4 oz. FDA UDI
- Model / Reference
- EREF2 EUDAMEDFDA UDIEIE414 EUDAMEDFDA UDIintra-extra oral latex elastics EUDAMEDLight Curing Composite 6a EUDAMED
- Description
- Ena HRi Enamel Function EF2 2.5g Light Curing Composite FDA UDIELASTOOSAS Italia Intraoral Latex Elastics 5000 pcs 1/4" - 4 oz. FDA UDI
Identifiers
- Catalog Number
- EREF2 FDA UDIEIE414 FDA UDI
- Primary DI / UDI-DI
- EMICEREF21 EUDAMEDFDA UDIEMICEIE4141 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM83H EUDAMED++EMICFAM1AEUX EUDAMED
- 510(k) Number
- K062906 FDA UDI
- FDA Product Code
- EBF FDA UDIKMY FDA UDI
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS EUDAMEDQ01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDIOrthodontic retainer FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.5525 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 UDIEUDAMED
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 UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 2.5 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
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- 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 (4)
- FDA UDI e87f7db2-3f62-47a3-99cc-6570d923138a 37 fields · synced Jul 20, 2026
- FDA UDI e442c15c-eef2-4716-8a3a-5f39d5227456 34 fields · synced May 30, 2026
- EUDAMED 342a3167-51c0-464f-8450-720180119463 61 fields · synced Jul 11, 2026
- EUDAMED af7b6a66-a9fc-441e-8f11-142c2502edd4 61 fields · synced Jul 20, 2026