Identity
- Trade Name
- ELECTROmatic M-L FDA UDI
- Generic Name
- Dental delivery system FDA UDI
- Model / Reference
- 1.012.8538 FDA UDI
Identifiers
- Catalog Number
- M-L FDA UDI
- Primary DI / UDI-DI
- EKAV101285380 FDA UDI
- 510(k) Number
- K163317 FDA UDI
- FDA Product Code
- EBW FDA UDI
- GMDN Term
- Dental delivery system 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
Category: Dental delivery system
ELECTROmatic M-L 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
K163317 also covers:
- ELECTROmatic C-L — KaVo Dental GmbH
- ELECTROmatic C-S — KaVo Dental GmbH
- ELECTROmatic M-S — KaVo Dental GmbH
- ELECTROmatic M/C — KaVo Dental GmbH
- ELECTROmatic PC-L — KaVo Dental GmbH
- ELECTROmatic PC-S — KaVo Dental GmbH
- ELECTROmatic PM-L — KaVo Dental GmbH
- ELECTROmatic PM-S — KaVo Dental GmbH
- ELECTROmatic PM/PC — KaVo Dental GmbH
- ELECTROmatic T2M-S — KaVo Dental GmbH
- ELECTROmatic TM — KaVo Dental GmbH
- ELECTROmatic TM-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 6c7ed77b-d99f-49de-bfc6-e4be905d3f6c 36 fields · synced May 30, 2026