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Excalibur Glider PRO sterile files
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref ZGE31PRO2Model Excalibur Glider PRO sterile files 31mm 12.5 4% (3 units)Ref TKZGE25PRO2Model Excalibur Glider PRO sterile files 25mm Training Kit
Identity
- Trade Name
- Excalibur Glider PRO sterile files EUDAMEDAVALON BIOMED FDA UDI
- Generic Name
- Manual endodontic file/rasp, single-use FDA UDI
- Model / Reference
- Excalibur Glider PRO sterile files 31mm 12.5 4% (3 units) EUDAMEDZGE31PRO2 EUDAMEDExcalibur Glider PRO sterile files 25mm Training Kit EUDAMEDTKZGE25PRO2 EUDAMEDExcalibur Glider PRO sterile 31mm (3 units) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975718058381 EUDAMEDFDA UDI06942512509692 EUDAMED
- Basic UDI-DI
- B-06975718058381 EUDAMEDB-06942512509692 EUDAMED
- FDA Product Code
- EKS FDA UDI
- EMDN Code
- Q010507 ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE EUDAMED
- GMDN Term
- Manual endodontic file/rasp, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Excalibur Glider PRO sterile files by Shenzhen Denco Medical Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06975718058381 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Denco Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000014271
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (3)
- EUDAMED 44506e89-f528-4e4b-bca3-e3fe0ac82436 61 fields · synced Jul 9, 2026
- EUDAMED 1313e69d-55a0-4d0d-8281-cde896d161ea 61 fields · synced May 18, 2026
- FDA UDI 06041723-d944-4165-a0ae-01424c99b744 33 fields · synced May 29, 2026