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iSy® Re-Set Removal tool
EUDAMEDFDA UDIClass I (EU MDR)
Ref P5900.1000
by ALTATEC GmbH
Identity
- Trade Name
- iSy® Re-Set Removal tool EUDAMEDiSy® Re-Set FDA UDI
- Generic Name
- Dental implant extractor FDA UDI
- Device Name
- iSy® Re-Set Removal tools set EUDAMEDFDA UDI
- Model / Reference
- P5900.1000 EUDAMEDFDA UDI
- Description
- iSy® Re-Set Removal tools set FDA UDI
Identifiers
- Catalog Number
- P5900.1000 FDA UDI
- Primary DI / UDI-DI
- 04099797022155 EUDAMEDE219P590010001 FDA UDI
- Basic UDI-DI
- 40997970006805000000000TG EUDAMED
- Secondary DI
- E219P590010001 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Dental implant extractor FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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® Re-Set Removal tool by ALTATEC GmbH — 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 | 40997970006805000000000TG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (2)
- EUDAMED 1fec1722-45ba-4fcb-8542-0bb5c1632540 61 fields · synced Jul 28, 2026
- FDA UDI 82f8594c-4eab-47f3-bf7f-f718e50bd3bb 35 fields · synced May 30, 2026