Lucitone 199® Disc
GUDID D0019060560
Dark Pink 35mm
Dentsply International Inc.
Dental appliance fabrication material, resin| Primary Device ID | D0019060560 |
| NIH Device Record Key | 3bfe145e-5ae2-48b2-9a1f-7e9a67fc53cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lucitone 199® Disc |
| Version Model Number | 906056 |
| 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
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
| Circumference | 35 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D0019060560 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K153590
FDA Product Code
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-11-10 |
| Device Publish Date | 2018-02-16 |
On-Brand Devices [Lucitone 199® Disc]
| D0019060580 | Light Reddish Pink 35mm |
| D0019060570 | Light 35mm |
| D0019060560 | Dark Pink 35mm |
| D0019060550 | Original 35mm |
Trademark Results [Lucitone 199]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUCITONE 199 73039389 1021866 Live/Registered |
DENTSPLY RESEARCH & DEVELOPMENT CORP. 1974-12-12 |
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