Identity
- Trade Name
- MiniEndo II FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system generator FDA UDI
- Device Name
- Ultrasonic Unit Type S - 110V FDA UDI
- Model / Reference
- 973-0236 FDA UDI
- Description
- Ultrasonic Unit Type S - 110V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00889989078114 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Ultrasonic dental scaling/debridement system generator 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Ultrasonic dental scaling/debridement system generator
MiniEndo II by Ormco Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic dental scaling/debridement system generator.
- Hu-Friedy — HU-FRIEDY MFG CO., LLC · Class II
- Hu-Friedy — HU-FRIEDY MFG CO., LLC · Class II
- VA370 Lux — NAKANISHI INC. · Class II
- Obtura Spartan — OBTURA SPARTAN ENDODONTICS · Class II
- Flight Dental Systems — FLIGHT DENTAL SYSTEMS USA INC. · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- OSADA ENAC OE-F15 — OSADA ELECTRIC CO., LTD. · Class II
- Hu-Friedy — HU-FRIEDY MFG CO., LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ormco Corporation
Sources (1)
- FDA UDI 597036bb-d26f-4f37-b002-ba44a4469c76 34 fields · synced Jun 9, 2026