Lucitone Digital Fuse™ 906195
GUDID D0019061950
Dentsply International Inc.
Dental appliance fabrication material, cured Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin| Primary Device ID | D0019061950 |
| NIH Device Record Key | 73b32eae-fca1-415c-92bc-9b2ed8a0e4e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lucitone Digital Fuse™ |
| Version Model Number | Step 3 - 3D Denture Sealer |
| Catalog Number | 906195 |
| Company DUNS | 606173334 |
| Company Name | Dentsply International Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
| Total Volume | 15 Milliliter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0019061950 [Primary] |
FDA Product Code
| EBD | Coating, filling material, resin |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-17 |
| Device Publish Date | 2019-09-09 |
On-Brand Devices [Lucitone Digital Fuse™]
| D0019062450 | Bonding Kit |
| D0019061950 | Step 3 - 3D Denture Sealer |
| D0019061920 | Step 2 - 3D Denture Bonding Agent - Pink Opaque |
| D0019061910 | Step 2 - 3D Denture Bonding Agent - Pink |
| D0019061900 | Step 2 - 3D Denture Bonding Agent - Dark Reddish P |
| D0019061890 | Step 2 - 3D Denture Bonding Agent - Light Reddish |
| D0019061880 | Step 2 - 3D Denture Bonding Agent - Light |
| D0019061870 | Step 2 - 3D Denture Bonding Agent - Original Opaqu |
| D0019061860 | Step 2 - 3D Denture Bonding Agent - Original |
| D0019061850 | Step 1 - 3D Tooth Conditioning Agent |
Trademark Results [Lucitone Digital Fuse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUCITONE DIGITAL FUSE 90747320 not registered Live/Pending |
Dentsply Sirona Inc. 2021-06-01 |
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