Identity
- Trade Name
- E-Type Adaptor FDA UDI
- Generic Name
- Dental handpiece maintenance unit FDA UDI
- Model / Reference
- E-Type Adaptor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560264573345 FDA UDI
- 510(k) Number
- K081811 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental handpiece maintenance unit
E-Type Adaptor by Nakanishi Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental handpiece maintenance unit.
- CareMaster — Beyes Dental Canada Inc · Class I
- Assistina 301+ — W & H Dentalwerk Bürmoos GmbH · Class I
- BeyesLube — Beyes Dental Canada Inc · Class I
- CHOICE PRO — HANDPIECE PARTS & REPAIRS, INC. · Class I
- Lubricare Maintenance System — Bien-Air Dental SA · Class I
- Lubrina 2 — J.MORITA MFG.CORP. · Class I
- CareMaster — Beyes Dental Canada Inc · Class I
- Adapter HPI — W & H Dentalwerk Bürmoos GmbH · Class I
Cleared under the same submission
K081811 also covers:
- BA-Adaptor — NAKANISHI INC.
- BA-Adaptor — NAKANISHI INC.
- F-Type Adaptor — NAKANISHI INC.
- F-Type Adaptor — NAKANISHI INC.
- F-Type Adaptor 4H — NAKANISHI INC.
- KV-Adaptor — NAKANISHI INC.
- MW-Adaptor — NAKANISHI INC.
- MWL Adaptor — NAKANISHI INC.
- Maintenance Oil — NAKANISHI INC.
- Maintenance Oil for iCare — NAKANISHI INC.
- PTL Adaptor — NAKANISHI INC.
- QD-Adaptor — NAKANISHI INC.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
Sources (1)
- FDA UDI 8c59bca3-5e61-47b2-ac41-ca5bdaf8b546 33 fields · synced Jun 8, 2026