Identity
- Trade Name
- OE-11L handpiece FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
- Model / Reference
- OE-11L FDA UDI
Identifiers
- Catalog Number
- 55374 FDA UDI
- Primary DI / UDI-DI
- 04582227425508 FDA UDI
- 510(k) Number
- K844250 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 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
No
FDA UDI
Over-the-Counter
Yes
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
Category: Ultrasonic dental scaling/debridement system handpiece
OE-11L handpiece by Osada Electric Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K844250 also covers:
- AP set 7 — OSADA ELECTRIC CO., LTD.
- Diamond file A set — OSADA ELECTRIC CO., LTD.
- Diamond file A1 — OSADA ELECTRIC CO., LTD.
- Diamond file A3 — OSADA ELECTRIC CO., LTD.
- Diamond file C — OSADA ELECTRIC CO., LTD.
- Diamond file L1 — OSADA ELECTRIC CO., LTD.
- IM Point — OSADA ELECTRIC CO., LTD.
- OSADA ENAC OE-F15 — OSADA ELECTRIC CO., LTD.
- PI01-L — OSADA ELECTRIC CO., LTD.
- PI01-R — OSADA ELECTRIC CO., LTD.
- PI02-L — OSADA ELECTRIC CO., LTD.
- Plugger set#20 — OSADA ELECTRIC CO., LTD.
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
- Osada Electric Co., Ltd.
Sources (1)
- FDA UDI b3b96928-5a22-4eee-93c3-e77727c85659 34 fields · synced May 30, 2026