Identity
- Trade Name
- Ena Seal ® FDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- Name: Ena Bond Seal Model: Light curing Sealer bonding agent Resin EUDAMEDENA-SEAL light-curing sealant 5 ml FDA UDI
- Model / Reference
- COSZ10 EUDAMEDFDA UDI
- Description
- ENA-SEAL light-curing sealant 5 ml FDA UDI
Identifiers
- Catalog Number
- COSZ10 FDA UDI
- Primary DI / UDI-DI
- EMICCOSZ101 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1A2B1CD8 EUDAMED
- 510(k) Number
- K072978 FDA UDI
- FDA Product Code
- DYH FDA UDI
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
- GMDN Term
- Dentine bonding agent/set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3750 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
- Total Volume — 5 Milliliter FDA UDI
Category: Dentine bonding agent/set
Ena Seal ® by Micerium Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dentine bonding agent/set.
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
- Tooth Shade Resin Material — Liaoning Upcera Co., Ltd. · Class II
Cleared under the same submission
K072978 also covers:
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
- Ena Bond ® — MICERIUM SPA
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 |
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Manufacturer
- Manufacturer
- Micerium Spa
Sources (2)
- FDA UDI 69132707-ee03-40ff-8ab3-4732fe87b69d 37 fields · synced Jun 19, 2026
- EUDAMED 4d92bebe-733c-46a7-8e93-c10c17c6e315 61 fields · synced Jun 19, 2026