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 |
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 Issuing Agency | Device ID |
---|---|
HIBCC | D0019061950 [Primary] |
EBD | Coating, filling material, resin |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-09-17 |
Device Publish Date | 2019-09-09 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LUCITONE DIGITAL FUSE 90747320 not registered Live/Pending |
Dentsply Sirona Inc. 2021-06-01 |