FDA device listing
Biocoat,CompCore AF,Itena,MICRODOSE SYRINGE,Mix-Tips,MultiMatch,MultiMatch Flow,NexTemp,RC-Prep,Traxodent
FDA device listing 1109502699 · Premier Dental Products Company
Key facts
| Proprietary names | Biocoat,CompCore AF,Itena,MICRODOSE SYRINGE,Mix-Tips,MultiMatch,MultiMatch Flow,NexTemp,RC-Prep,Traxodent |
|---|---|
| Owner/operator | Premier Dental Products Company |
| Owner/operator number | 2511556 |
| Product codes | EID |
| Device names | EID - Syringe, Restorative And Impression Material |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | PREMIER DENTAL PRODUCTS CO. |
| Establishment registrations | 2511556 |
| FEI numbers | 2511556 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler, Specification Developer |
| 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