Identity
- Trade Name
- Ti-Max X FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Model / Reference
- MDA0000034 EUDAMEDC609 EUDAMEDX57L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560264510913 EUDAMEDFDA UDI
- Basic UDI-DI
- 456022498000003472 EUDAMED
- Direct Marketing DI
- 04560264578913 EUDAMED
- FDA Product Code
- EGS FDA UDI
- EMDN Code
- Z12119007 DENTAL PROPHYLAXIS EQUIPMENT EUDAMED
- GMDN Term
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
C609 by Nakanishi Inc. — Class IIa — 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 | 456022498000003472 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
- EUDAMED SRN
- JP-MF-000011271
- Authorised Representative
- NSK Europe GmbH DE-AR-000007040
Sources (2)
- EUDAMED 03fac02f-f33b-4d1b-8d6f-4e06f52d314a 61 fields · synced Jun 18, 2026
- FDA UDI a9e39718-5c40-4307-acf9-d0745e1aa8e5 32 fields · synced May 30, 2026