Identity
- Trade Name
- Lubrina 2 FDA UDI
- Generic Name
- Dental handpiece maintenance unit FDA UDI
- Device Name
- Handpiece Maintenance Unit FDA UDI
- Model / Reference
- HIM-2-EX1 FDA UDI
- Description
- Handpiece Maintenance Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04548213044788 FDA UDI
- 510(k) Number
- K190509 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental handpiece maintenance unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Category: Dental handpiece maintenance unit
Lubrina 2 by J.morita Mfg.corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental handpiece maintenance unit.
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- Maintenance Oil — NAKANISHI INC. · Class I
- CareMaster — Beyes Dental Canada Inc · Class I
- Assistina 301+ — W & H Dentalwerk Bürmoos GmbH · Class I
- F-Type Adaptor — NAKANISHI INC. · Class I
- F-Type Adaptor 4H — NAKANISHI INC. · Class I
- BeyesLube — Beyes Dental Canada Inc · Class I
Cleared under the same submission
K190509 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- J.morita Mfg.corp.
Sources (2)
- FDA UDI 7cb772de-ce25-4f29-b9f0-769dba00b7c9 35 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026