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SCREW-LINE Osteotome
EUDAMEDFDA UDIClass I (EU MDR)
Ref J5420.3310
by ALTATEC GmbH
Identity
- Trade Name
- SCREW-LINE Osteotome EUDAMEDOsteotome SCREW-LINE FDA UDI
- Generic Name
- Dental osteotome FDA UDI
- Device Name
- Reusable surgical instruments (Osteotome) EUDAMEDOsteotome SCREW-LINE, angled, concave, Ø 3.3 mm FDA UDI
- Model / Reference
- J5420.3310 EUDAMEDFDA UDI
- Description
- Osteotome SCREW-LINE, angled, concave, Ø 3.3 mm FDA UDI
Identifiers
- Catalog Number
- J5420.3310 FDA UDI
- Primary DI / UDI-DI
- 04099797996593 EUDAMEDE219J542033101 FDA UDI
- Basic UDI-DI
- 4099797000010100000000083 EUDAMED
- Secondary DI
- E219J542033101 EUDAMED
- FDA Product Code
- EMM FDA UDI
- EMDN Code
- L150101 ODONTOSTOMATOLOGY OSTEOTOMES, REUSABLE EUDAMED
- GMDN Term
- Dental osteotome FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 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
Yes
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
SCREW-LINE Osteotome 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 | 4099797000010100000000083 | 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 27a76acf-b1e3-4f50-a34b-49d3bd658014 61 fields · synced Jul 13, 2026
- FDA UDI bc9a991f-928b-4d68-b003-7e49adb627fd 35 fields · synced May 30, 2026