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CLEARsplint Disc BES
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BES 95x25 Clover Edge BlueModel Model 01: CLEARsplint, CLEARsplint CAD/CAM PRO Model 02: The Original CLEARsplint Disc
Identity
- Trade Name
- CLEARsplint Disc BES EUDAMEDCLEARSPLINT FDA UDI
- Generic Name
- Mouthguard, single-use FDA UDI
- Device Name
- CLEARsplint EUDAMEDClearsplint Disc 95mm x 25mm Clover Edge Blue BES 1 Unit FDA UDI
- Model / Reference
- Model 01: CLEARsplint, CLEARsplint CAD/CAM PRO Model 02: The Original CLEARsplint Disc EUDAMEDBES 95x25 Clover Edge Blue EUDAMEDPCSD2595ZBESB1 FDA UDI
- Description
- Clearsplint Disc 95mm x 25mm Clover Edge Blue BES 1 Unit FDA UDI
Identifiers
- Catalog Number
- PCSD2595ZBESB1 FDA UDI
- Primary DI / UDI-DI
- D810PCSD2595ZBESB111 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D810ClearsplintKM EUDAMED
- Direct Marketing DI
- D810PCSD2595ZBESB111 EUDAMED
- 510(k) Number
- K111828 FDA UDI
- FDA Product Code
- MQC FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Mouthguard, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
CLEARsplint Disc BES by Astron Dental — Class IIa — 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 | ++D810ClearsplintKM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Astron Dental
- EUDAMED SRN
- US-MF-000034006
- Authorised Representative
- Kentzler-Kaschner Dental GmbH DE-AR-000006367
Sources (2)
- EUDAMED e53cc4b5-faab-4527-ad07-58cda45611f0 61 fields · synced Jun 18, 2026
- FDA UDI 012869ef-0c5b-4796-a6ab-98f442f50ccf 36 fields · synced May 30, 2026