FDA device listing
2 grit diamonds,All Ceramic Supermax,Bambino Series,Brix Diamond Disc,Brix HP diamond,Interflex diamond disc,KS…
FDA device listing 1963371477 · NTI-KAHLA GMBH, ROTARY DENTAL INSTRUMENTS
Key facts
| Proprietary names | 2 grit diamonds,All Ceramic Supermax,Bambino Series,Brix Diamond Disc,Brix HP diamond,Interflex diamond disc,KS Series,MADC burs,nano prep,NTI,NTI Axial Reduction Bur,NTI diamond strip,NTI Easy Chamfer Diamonds,NTI Guide Pin Diamond,NTI Handpiece Crown Cutter,NTI InPrep Diamonds,NTI LazyBur,NTI ProxyStrip,NTI serrated diamond strip,NTI Sintered HP,NTI Supermax,Superflex diamond disc,T.D.F… |
|---|---|
| Owner/operator | NTI-KAHLA GMBH, ROTARY DENTAL INSTRUMENTS |
| Owner/operator number | 9022916 |
| Product codes | DZP |
| Device names | DZP - Instrument, Diamond, Dental |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4535 |
| Review panels | Dental |
| Registered establishments | NTI-KAHLA GMBH, ROTARY DENTAL INSTRUMENTS |
| Establishment registrations | 9681565 |
| FEI numbers | 3002515789 |
| 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