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iSy® Drill extension
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P5002.0006
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Drill extension EUDAMEDFDA UDI
- Generic Name
- Dental drill bit extension FDA UDI
- Device Name
- iSy® Drill extension, ISO shaft EUDAMEDFDA UDI
- Model / Reference
- P5002.0006 EUDAMEDFDA UDI
- Description
- iSy® Drill extension, ISO shaft FDA UDI
Identifiers
- Catalog Number
- P5002.0006 FDA UDI
- Primary DI / UDI-DI
- 04099797021561 EUDAMEDE219P500200061 FDA UDI
- Basic UDI-DI
- 40997970004302000000000GE EUDAMED
- Secondary DI
- E219P500200061 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Dental drill bit extension FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
iSy® Drill extension by ALTATEC GmbH — 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 | 40997970004302000000000GE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED f6d8c004-e1b0-40bf-a734-f0b8e6c08ca5 61 fields · synced Jul 18, 2026
- FDA UDI 2168aa02-3a1d-4507-b2e4-dcbbc9af5989 35 fields · synced May 30, 2026