FDA device listing
Bisacryl NicTone,Nic Tone Acrylic Resins,Nic Tone PolyCril,Nic Tone Selfcure Liquid
FDA device listing 1890375851 · MANUFACTURERA DENTAL CONTINENTAL
Key facts
| Proprietary names | Bisacryl NicTone,Nic Tone Acrylic Resins,Nic Tone PolyCril,Nic Tone Selfcure Liquid |
|---|---|
| Owner/operator | MANUFACTURERA DENTAL CONTINENTAL |
| Owner/operator number | 9032760 |
| Premarket submissions | K991577 |
| Product codes | EBG, EBI, OCL |
| Device names | EBG - Crown And Bridge, Temporary, Resin, EBI - Resin, Denture, Relining, Repairing, Rebasing, OCL - Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3760, 872.3770, 878.4400 |
| Review panels | Dental, General & Plastic Surgery |
| Registered establishments | MANUFACTURERA DENTAL CONTINENTAL, REKO DENTAL, LLC |
| Establishment registrations | 2087259, 9616065 |
| FEI numbers | 1000531402, 3003381355 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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