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Orientierungsschabolen
EUDAMEDFDA UDIClass I (EU MDR)
Ref J3551.0001
by ALTATEC GmbH
Identity
- Trade Name
- Orientierungsschabolen EUDAMEDOrientation Gauge FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Dental implantation depth/angle gauge, reusable EUDAMEDOrientation Gauge, Ø 2.0 FDA UDI
- Model / Reference
- J3551.0001 EUDAMEDFDA UDI
- Description
- Orientation Gauge, Ø 2.0 FDA UDI
Identifiers
- Catalog Number
- J3551.0001 FDA UDI
- Primary DI / UDI-DI
- 04099797011500 EUDAMEDE219J355100011 FDA UDI
- Basic UDI-DI
- 40997970008007000000000NL EUDAMED
- Secondary DI
- E219J355100011 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical drill guide, reusable 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
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
Orientierungsschabolen 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 | 40997970008007000000000NL | 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 9731d3d6-2454-47a5-9525-c96cfa38a341 61 fields · synced Jun 18, 2026
- FDA UDI 4b501697-f56e-4181-9911-871b88b3f3d0 35 fields · synced May 30, 2026