Identity
- Trade Name
- SMARTmatic PROPHY S19 K FDA UDI
- Generic Name
- Dental power tool system handpiece, line-powered FDA UDI
- Model / Reference
- 1.011.6741 FDA UDI
Identifiers
- Catalog Number
- S19 K FDA UDI
- Primary DI / UDI-DI
- EKAV101167410 FDA UDI
- 510(k) Number
- K163239 FDA UDI
- FDA Product Code
- EFA 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
SMARTmatic PROPHY S19 K by KaVo Dental GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental power tool system handpiece, line-powered.
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Cleared under the same submission
K163239 also covers:
- A-dec — A-Dec, Inc.
- Elements 8:1 — KaVo Dental GmbH
- SMARTmatic ENDO S321 — KaVo Dental GmbH
- SMARTmatic ENDO S81 — KaVo Dental GmbH
- SMARTmatic PROPHY S19 — KaVo Dental GmbH
- SMARTmatic PROPHY S31 — KaVo Dental GmbH
- SMARTmatic PROPHY S33 — KaVo Dental GmbH
- SMARTmatic S10 — KaVo Dental GmbH
- SMARTmatic S10 K — KaVo Dental GmbH
- SMARTmatic S10 S — KaVo Dental GmbH
- SMARTmatic S20 — KaVo Dental GmbH
- SMARTmatic S20 K — 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 0100929c-6b3b-44ef-aa6f-7adbd5696624 36 fields · synced May 30, 2026