Identity
- Trade Name
- Ti-Max FDA UDI
- Generic Name
- Pneumatic dental scaling/debridement system handpiece FDA UDI
- Model / Reference
- S950 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560224977497 FDA UDI
- 510(k) Number
- K991021 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Pneumatic dental scaling/debridement system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Ti-Max by Nakanishi Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
Sources (1)
- FDA UDI a0874844-ba9d-4f38-8d23-261c1bae92bf 34 fields · synced Jun 8, 2026