Identity
- Trade Name
- INTRAmatic 31 ES FDA UDI
- Generic Name
- Dental power tool system handpiece, line-powered FDA UDI
- Device Name
- This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry. FDA UDI
- Model / Reference
- 1.003.1109 FDA UDI
- Description
- This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry. FDA UDI
Identifiers
- Catalog Number
- 31 ES FDA UDI
- Primary DI / UDI-DI
- EKAV100311090 FDA UDI
- 510(k) Number
- K073478 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental power tool system handpiece, line-powered 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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental power tool system handpiece, line-powered
INTRAmatic 31 ES by KaVo Dental GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K073478 also covers:
- A-dec — A-Dec, Inc.
- A-dec — A-Dec, Inc.
- EXPERT LUX Case 680465LRN — KaVo Dental GmbH
- EXPERTmatic E15 C — KaVo Dental GmbH
- EXPERTmatic E15 L — KaVo Dental GmbH
- EXPERTmatic E20 C — KaVo Dental GmbH
- EXPERTmatic E25 C — KaVo Dental GmbH
- EXPERTmatic E25 L — KaVo Dental GmbH
- EXPERTmatic E31 C — KaVo Dental GmbH
- EXPERTtorque E675 LMW — KaVo Dental GmbH
- EXPERTtorque E679 L — KaVo Dental GmbH
- EXPERTtorque LUX E680 L — KaVo Dental GmbH
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
- KaVo Dental GmbH
Sources (1)
- FDA UDI dd374443-62cd-4300-b6d2-30ad29d23fb5 37 fields · synced May 30, 2026