Identity
- Trade Name
- Ena HRI ® FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Ena HRi Enamel Kit 2.5g x 3 colors UE1, UE2, UE3 Light Curing Composite FDA UDI
- Model / Reference
- ER3E FDA UDI
- Description
- Ena HRi Enamel Kit 2.5g x 3 colors UE1, UE2, UE3 Light Curing Composite FDA UDI
Identifiers
- Catalog Number
- ER3E FDA UDI
- Primary DI / UDI-DI
- EMICER3E0 FDA UDI
- 510(k) Number
- K062906 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 7.5 Gram FDA UDI
Category: Dental composite resin
Ena HRI ® by Micerium Spa — Class II — FDA UDI — listed in FDA GUDID — 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
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- 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Micerium Spa
Sources (1)
- FDA UDI 115fefb6-2761-45c6-9753-fb7e6fbda738 37 fields · synced May 31, 2026