CERAMIC 21-111-11
GUDID D80721111111
CERAMIC BONDABLE BUTTON
DENTSPLY SIRONA ORTHODONTICS INC.
Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube Orthodontic tube| Primary Device ID | D80721111111 |
| NIH Device Record Key | 4c12eb6f-7c9d-4ed3-b59f-c15f75a91904 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CERAMIC |
| Version Model Number | 21-111-11 |
| Catalog Number | 21-111-11 |
| Company DUNS | 116903307 |
| Company Name | DENTSPLY SIRONA ORTHODONTICS INC. |
| Device Count | 5 |
| DM Exempt | true |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D80721111110 [Unit of Use] |
| HIBCC | D80721111111 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080906
FDA Product Code
| NJM | Bracket, ceramic, orthodontic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2017-06-26 |
Devices Manufactured by DENTSPLY SIRONA ORTHODONTICS INC.
| D74666591921 - Sculpt I.Q. | 2024-03-28 Optic protection cap for handpiece (5 pieces) |
| D74666591011 - Sculpt I.Q. | 2024-02-29 Sculpt I.Q. Laser, USA |
| D74666593091 - Sculpt I.Q. | 2024-02-29 MultiTip 8mm, therapy light guide |
| D74666592001 - Sculpt I.Q. | 2024-02-02 EasyBend - Bending tool |
| D74666592181 - Sculpt I.Q. | 2024-02-02 Fibercutter |
| D74666592911 - Sculpt I.Q. | 2024-02-02 EasyTip Endo Pack 25 |
| D74666595561 - Sculpt I.Q. | 2024-02-02 Wireless Foot Control |
| D74666591841 - Sculpt I.Q. | 2024-01-26 Handpiece sleeve with keypad |
Trademark Results [CERAMIC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CERAMIC 88821218 not registered Live/Pending |
3BOX Inc. 2020-03-04 |
 CERAMIC 88486783 not registered Live/Pending |
Strong, David Andrew 2019-06-24 |
 CERAMIC 77012995 3545709 Live/Registered |
SPX Cooling Technologies, Inc. 2006-10-03 |
 CERAMIC 74001169 not registered Dead/Abandoned |
WILKINSON SWORD LIMITED 1989-11-16 |
 CERAMIC 71683442 0624100 Dead/Expired |
J. SCHOENEMAN, INC. 1955-03-14 |
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