FDA device listing
Gutta Percha Point, Model: for Protaper with LengthMark,Gutta Percha Point, Model: Taper0.02, 0.04/0.06, for…
FDA device listing 1065885840 · Dongguan Integrity Medical Instrument Co.,Ltd.
Key facts
| Proprietary names | Gutta Percha Point, Model: for Protaper with LengthMark,Gutta Percha Point, Model: Taper0.02, 0.04/0.06, for Protaper,Taper 0.02 with LengthMark,Taper 0.04/0/06 with LengthMark |
|---|---|
| Owner/operator | Dongguan Integrity Medical Instrument Co.,Ltd. |
| Owner/operator number | 10083415 |
| Product codes | EKM |
| Device names | EKM - Gutta-Percha |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3850 |
| Review panels | Dental |
| Registered establishments | DONGGUAN INTEGRITY MEDICAL INSTRUMENT CO.,LTD. |
| Establishment registrations | 3021284315 |
| FEI numbers | 3021284315 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, 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