Identity
- Trade Name
- Occlude Red Jumbo, 75g EUDAMEDOcclude Aerosol Articulation Marking 75g Red FDA UDI
- Generic Name
- Dental articulation paste/solution FDA UDI
- Device Name
- Occlude EUDAMEDAerosol articulation marking spray, 75 grams. red FDA UDI
- Model / Reference
- 05325 EUDAMEDFDA UDI
- Description
- Aerosol articulation marking spray, 75 grams. red FDA UDI
Identifiers
- Catalog Number
- 05325 FDA UDI
- Primary DI / UDI-DI
- 00310866000237 EUDAMEDFDA UDI
- Basic UDI-DI
- 03108661003FT EUDAMED
- FDA Product Code
- EFH FDA UDI
- EMDN Code
- Q01020202 SPRAY AND LIQUID DENTAL CONTACT INDICATORS EUDAMED
- GMDN Term
- Dental articulation paste/solution FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6140 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
No
FDA UDI
Occlude Red Jumbo, 75g by Pascal Company, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 03108661003FT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pascal Company Inc.
- EUDAMED SRN
- US-MF-000032036
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6a27a435-eb9a-4543-bd60-52ba29019adc 61 fields · synced Aug 2, 2026
- FDA UDI 919c45ec-7442-4d70-8a08-812fc8a16cac 36 fields · synced May 29, 2026