Identity
- Trade Name
- SURGmatic S11 L FDA UDI
- Generic Name
- Dental power tool handpiece motorless component FDA UDI
- Device Name
- Dental straight and contra-angle handpieces EUDAMED
- Model / Reference
- 1.009.1010 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1.009.1010 FDA UDI
- Primary DI / UDI-DI
- EKAV100910100 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EKAVG502Z5 EUDAMED
- 510(k) Number
- K140308 FDA UDI
- FDA Product Code
- EBW FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
- GMDN Term
- Dental power tool handpiece motorless component FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental power tool handpiece motorless component
SURGmatic S11 L by KaVo Dental GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K140308 also covers:
- EXPERTsurg LUX — KaVo Dental GmbH
- INTRA LUX S600 LED — KaVo Dental GmbH
- MASTERsurg LUX Wireless — KaVo Dental GmbH
- SM5 — KaVo Dental GmbH
- SURGmatic Head S201 L Pro — KaVo Dental GmbH
- SURGmatic Head S201 XL Pro — KaVo Dental GmbH
- SURGmatic S11 C — KaVo Dental GmbH
- SURGmatic S201 C — KaVo Dental GmbH
- SURGmatic S201 L — KaVo Dental GmbH
- SURGmatic S201 L Pro — KaVo Dental GmbH
- SURGmatic S201 XC — KaVo Dental GmbH
- SURGmatic S201 XL — KaVo Dental GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| 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 (2)
- FDA UDI bcee5246-1e04-4394-ac2c-c6ea5484999d 36 fields · synced Jul 9, 2026
- EUDAMED bb72d417-02ae-402d-b4b6-9ea7305a76fe 61 fields · synced Jul 9, 2026