FDA device listing
elements 8:1 - 1.011.6786,SMARTmatic ENDO S321 - 1.011.6790,SMARTmatic ENDO S81 - 1.011.6780,SMARTmatic PROPHY S19…
FDA device listing 1205017262 · KaVo Dental GmbH
Key facts
| Proprietary names | elements 8:1 - 1.011.6786,SMARTmatic ENDO S321 - 1.011.6790,SMARTmatic ENDO S81 - 1.011.6780,SMARTmatic PROPHY S19 - 1.011.6740,SMARTmatic PROPHY S19 K - 1.011.6741,SMARTmatic PROPHY S31 - 1.011.6760,SMARTmatic PROPHY S31 K - 1.011.6761,SMARTmatic PROPHY S33 - 1.011.6800,SMARTmatic S10 - 1.011.6730,SMARTmatic S10 K - 1.011.6731,SMARTmatic S10 S - 1.011.6732,SMARTmatic S20 - 1.011.6750,SMARTmatic… |
|---|---|
| Owner/operator | KaVo Dental GmbH |
| Owner/operator number | 10042139 |
| Premarket submissions | K163239 |
| Product codes | EFA |
| Device names | EFA - Handpiece, Belt And/Or Gear Driven, Dental |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4200 |
| Review panels | Dental |
| Registered establishments | KAVO DENTAL GMBH |
| Establishment registrations | 3003637274 |
| FEI numbers | 3003637274 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database