Identity
- Trade Name
- ARETE FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
- Device Name
- High-Speed Fiber-Optic Handpiece FDA UDI
- Model / Reference
- BUR-4HUEX-O-WH FDA UDI
- Description
- High-Speed Fiber-Optic Handpiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04548213053551 FDA UDI
- 510(k) Number
- K061701 FDA UDI
- FDA Product Code
- EFA FDA UDI
- GMDN Term
- Dental surgical power tool motorized handpiece/set, pneumatic 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
Yes
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental surgical power tool motorized handpiece/set, pneumatic
Arete by J.morita Mfg.corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental surgical power tool motorized handpiece/set, pneumatic.
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- Flight Dental Systems — Flight Dental Systems · Class I
Cleared under the same submission
K061701 also covers:
- ARETE — J.MORITA MFG.CORP.
- ARETE — J.MORITA MFG.CORP.
- ARETE — J.MORITA MFG.CORP.
- ARETE — J.MORITA MFG.CORP.
- ARETE — J.MORITA MFG.CORP.
- ARETE — J.MORITA MFG.CORP.
- ARETE — J.MORITA MFG.CORP.
- ARETE — J.MORITA MFG.CORP.
- Midwest 45 FBE NFO — J.MORITA MFG.CORP.
- Midwest 45 K-Style NFO — J.MORITA MFG.CORP.
- STERLING — J.MORITA MFG.CORP.
- STERLING — J.MORITA MFG.CORP.
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
- J.morita Mfg.corp.
Sources (1)
- FDA UDI e05b84dd-3ebd-452f-a306-03b66ae3e6ec 35 fields · synced May 30, 2026