Identity
- Trade Name
- Diamantstreifen EUDAMEDNTI FDA UDI
- Generic Name
- Dental abrasive strip, reusable FDA UDI
- Device Name
- Diamantstreifen EUDAMEDNTI Serrated Diamond Strip 3.75mm - F FDA UDI
- Model / Reference
- FS3-FX EUDAMEDFDA UDI
- Description
- NTI Serrated Diamond Strip 3.75mm - F FDA UDI
Identifiers
- Catalog Number
- FS3-FX FDA UDI
- Primary DI / UDI-DI
- +E310FS3FX1 EUDAMEDE310FS3FX1 FDA UDI
- Basic UDI-DI
- ++E310DiaStFuellDF EUDAMED
- Unit of Use DI
- +E310FS3FX0 EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- L159019 DENTAL FINISHING RASPS AND FILES, REUSABLE EUDAMED
- GMDN Term
- Dental abrasive strip, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4535 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
No
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
Diamantstreifen by NTI - Kahla GmbH Rotary Dental Instruments — 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 | ++E310DiaStFuellDF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- NTI-Kahla GmbH Rotary Dental Instruments
- EUDAMED SRN
- DE-MF-000009451
Sources (2)
- EUDAMED f91c0bbc-15f6-4cc8-b881-db286a6fe4a5 61 fields · synced Oct 8, 2026
- FDA UDI 00faaab2-34e7-4be7-8d27-6d88bcf359a6 34 fields · synced May 30, 2026