FDA device listing
ADS Chlorhexidine Irrigation Solution,ADS EDTA Irrigation Solution,ADS Enhanced Sodium Hypochlorite Solution,ADS Sodium…
FDA device listing 1925786145 · Dharma Research, Inc.
Key facts
| Proprietary names | ADS Chlorhexidine Irrigation Solution,ADS EDTA Irrigation Solution,ADS Enhanced Sodium Hypochlorite Solution,ADS Sodium Hypochlorite Solution,Calix-CHG Chlorhexidine Irrigation Solution,Calix-E EDTA Irrigation Solution,Calix Sodium Hypochlorite Solution,Calix-X Enhanced Sodium Hypochlorite Solution,Sherbet Chlorhexidine Irrigation Solution,Sherbet EDTA Irrigation Solution,Sherbet Enhanced Sodium… |
|---|---|
| Owner/operator | Dharma Research, Inc. |
| Owner/operator number | 10043856 |
| Product codes | EIC |
| Device names | EIC - Syringe, Periodontic, Endodontic, Irrigating |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | Dharma Research/Medeco International |
| Establishment registrations | 3010131268 |
| FEI numbers | 3010131268 |
| Establishment operations | Contract Manufacturer, 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