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Articulating Papers Horseshoe, blue/red, thick
EUDAMEDFDA UDIClass I (EU MDR)
Ref 36416
Identity
- Trade Name
- Articulating Papers Horseshoe, blue/red, thick EUDAMEDARTICULATING PAPER HORSESHOE, BLUE/RED, THICK FDA UDI
- Generic Name
- Dental articulation paper FDA UDI
- Device Name
- Articulating Paper EUDAMEDArticulating Papers are occlusal marking papers, whose aim is to highlight occlusion contacts, by creating a mark on the corresponding teeth surfaces (ink transfer). The products are used in the dentistry field. Pack of 6x12 sheets FDA UDI
- Model / Reference
- 36416 EUDAMEDFDA UDI
- Description
- Articulating Papers are occlusal marking papers, whose aim is to highlight occlusion contacts, by creating a mark on the corresponding teeth surfaces (ink transfer). The products are used in the dentistry field. Pack of 6x12 sheets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640159161752 EUDAMEDFDA UDI
- Basic UDI-DI
- 764015916ART_PAPERXS EUDAMED
- FDA Product Code
- EFH FDA UDI
- EMDN Code
- Q019004 DENTAL COTTON ROLLS EUDAMED
- GMDN Term
- Dental articulation paper FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6140 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Articulating Papers Horseshoe, blue/red, thick by Produits Dentaires SA — 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 | 764015916ART_PAPERXS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Produits Dentaires SA
- EUDAMED SRN
- CH-MF-000023147
- Authorised Representative
- PD DENTAL EU SAS FR-AR-000017144
Sources (2)
- EUDAMED 42878d69-7b9f-44fa-978a-4d69a7208a16 61 fields · synced Jun 18, 2026
- FDA UDI 87d005d5-a482-4d12-969a-55f341bebb6d 33 fields · synced May 30, 2026