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SCREW-LINE Pre-Osteotome
EUDAMEDFDA UDIClass I (EU MDR)
Ref J5419.2800
by ALTATEC GmbH
Identity
- Trade Name
- SCREW-LINE Pre-Osteotome EUDAMEDOsteotome SCREW-LINE FDA UDI
- Generic Name
- Dental osteotome FDA UDI
- Device Name
- Reusable surgical instruments (Osteotome) EUDAMEDPre-Osteotome SCREW-LINE, straight, concave FDA UDI
- Model / Reference
- J5419.2800 EUDAMEDFDA UDI
- Description
- Pre-Osteotome SCREW-LINE, straight, concave FDA UDI
Identifiers
- Catalog Number
- J5419.2800 FDA UDI
- Primary DI / UDI-DI
- 04099797996562 EUDAMEDE219J541928001 FDA UDI
- Basic UDI-DI
- 4099797000010100000000083 EUDAMED
- Secondary DI
- E219J541928001 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 Pre-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 f5271f08-2fca-4cf8-9191-d71982e46cd9 61 fields · synced Sep 17, 2026
- FDA UDI 7484ca52-1d30-44c9-b5f2-3b70e82392da 35 fields · synced May 30, 2026