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iSy® Single patient form drill
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P5040.3801
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Single patient form drill EUDAMEDiSy® Form drill FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- iSy® Single Patient Form drill EUDAMEDiSy® Single patient form drill d 3.8 (3 piece) FDA UDI
- Model / Reference
- P5040.3801 EUDAMEDFDA UDI
- Description
- iSy® Single patient form drill d 3.8 (3 piece) FDA UDI
Identifiers
- Catalog Number
- P5040.3801 FDA UDI
- Primary DI / UDI-DI
- 04099797021592 EUDAMEDE219P504038011 FDA UDI
- Basic UDI-DI
- 40997970004301000000000FH EUDAMED
- Secondary DI
- E219P504038011 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
iSy® Single patient form drill 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 | 40997970004301000000000FH | 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 01df3319-70a6-4b88-9a87-dbfd4f39bb5b 61 fields · synced Jun 19, 2026
- FDA UDI 1556d34a-85fa-4615-9bb1-7c4672411c1e 35 fields · synced May 30, 2026