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Pure Bond Dispenser
EUDAMEDFDA UDIClass I (EU MDR)
Ref PBD-S Model PBD-S
by Jordco, Inc.
Identity
- Trade Name
- Pure Bond Dispenser FDA UDI
- Generic Name
- Dental material chairside light-protection container FDA UDI
- Device Name
- PURE BOND DISPENSER EUDAMEDPure Bond Dispenser pack FDA UDI
- Model / Reference
- PBD-S EUDAMEDFDA UDI
- Description
- Pure Bond Dispenser pack FDA UDI
Identifiers
- Catalog Number
- PBD-S FDA UDI
- Primary DI / UDI-DI
- 00859611006211 EUDAMEDFDA UDI
- Basic UDI-DI
- 00859611PUREBONDDISP68 EUDAMED
- FDA Product Code
- KXR FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental material chairside light-protection container FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3140 FDA UDI
- Market of Registration
- Malta 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
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pure Bond Dispenser by Jordco, 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 | 00859611PUREBONDDISP68 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jordco, Inc.
- EUDAMED SRN
- US-MF-000021671
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 4a5e3350-dfaf-4979-ba99-e810cf01d69b 61 fields · synced Jun 19, 2026
- FDA UDI c05710ad-3621-4639-bb96-58088f150a9c 35 fields · synced May 30, 2026