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Auto-Cure Activator
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 100060Ref 100060ITRef 100060RO
Identity
- Trade Name
- Auto-Cure Activator EUDAMEDFDA UDI
- Generic Name
- Dentine bonding agent/set FDA UDI
- Device Name
- Bonding Agents EUDAMED
- Model / Reference
- 100060 EUDAMEDFDA UDI100060IT EUDAMED100060RO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290115052886 EUDAMEDFDA UDI07290115051346 EUDAMED07290115050936 EUDAMED
- Basic UDI-DI
- 72901150510020094 EUDAMED
- 510(k) Number
- K933766 FDA UDI
- FDA Product Code
- KLE 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
- 872.3200 FDA UDI
- Market of Registration
- Belgium 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 10 Milliliter FDA UDI
Category: Dentine bonding agent/set
Auto-Cure Activator by B.J.M. Laboratories Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 72901150510020094 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- B.J.M. Laboratories Ltd.
- EUDAMED SRN
- IL-MF-000034121
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED 37b1148a-645d-4558-8a44-26e73604269c 61 fields · synced Jul 27, 2026
- EUDAMED 287de938-b4c2-412d-a0cc-05c6f5f4c7be 61 fields · synced May 18, 2026
- EUDAMED 2ac44c24-55af-4573-b082-bad44ea8aa06 61 fields · synced May 19, 2026
- FDA UDI 2704b681-9a8f-4f96-a594-6342de98346b 35 fields · synced May 30, 2026