FDA device listing
193.01XLIP - SPAT DE BOUCHE HEI N1XL I.P,MODELLING SPATULA CPR01 reference 194.12SI-modeling instr. bliss n1,MODELLING…
FDA device listing 1422860351 · PRODONT-HOLLIGER S.A.S.
Key facts
| Proprietary names | 193.01XLIP - SPAT DE BOUCHE HEI N1XL I.P,MODELLING SPATULA CPR01 reference 194.12SI-modeling instr. bliss n1,MODELLING SPATULA CPR02 reference 194.13SI-modeling instr. bliss n2,MODELLING SPATULA CPR05 rference 194.16SI-modeling instr. bliss n5,MODELLING SPATULA OP55 reference 192.05SI-modelling instr. op55 bliss |
|---|---|
| Owner/operator | PRODONT-HOLLIGER S.A.S. |
| Owner/operator number | 8020817 |
| Product codes | EIY |
| Device names | EIY - Instrument, Filling, Plastic, Dental |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | PRODONT-HOLLIGER S.A.S. |
| Establishment registrations | 9611899 |
| FEI numbers | 3002807935 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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