Identity
- Trade Name
- EsTemp NE Automix EUDAMEDEstemp NE Temporary Cement FDA UDI
- Generic Name
- Ethoxy benzoic acid dental cement FDA UDI
- Device Name
- EsTemp NE EUDAMED
- Model / Reference
- #1305PAU EUDAMED101-1012 FDA UDI
Identifiers
- Catalog Number
- 101-1012 FDA UDI
- Primary DI / UDI-DI
- 08809262954227 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809262954227 EUDAMED
- 510(k) Number
- K100290 FDA UDI
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
- GMDN Term
- Ethoxy benzoic acid dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
Category: Ethoxy benzoic acid dental cement
Estemp NE Temporary Cement by Spident Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K100290 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spident Co., Ltd.
Sources (2)
- FDA UDI 61d36bb5-3124-4971-8c43-40db5ef2bcb7 34 fields · synced Jun 19, 2026
- EUDAMED ff7b8b24-5932-430e-997b-265164ee6f76 61 fields · synced Jun 19, 2026