Identity
- Trade Name
- INTRAmatic 181 M FDA UDI
- Generic Name
- Dental surgical power tool motor, pneumatic FDA UDI
- Device Name
- This is a medical device.This is a medical device. FDA UDI
- Model / Reference
- 0.535.5250 FDA UDI
- Description
- This is a medical device.This is a medical device. FDA UDI
Identifiers
- Catalog Number
- 181 M FDA UDI
- Primary DI / UDI-DI
- EKAV053552500 FDA UDI
- 510(k) Number
- K073478 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental surgical power tool motor, 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
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 surgical power tool motor, pneumatic
INTRAmatic 181 M 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- KaVo Dental GmbH
Sources (1)
- FDA UDI a7cba0f0-580a-4728-9894-882b5e5d928a 37 fields · synced Jun 1, 2026