CERAMIC 21-111-11
GUDID D80721111111
CERAMIC BONDABLE BUTTON
DENTSPLY SIRONA ORTHODONTICS INC.
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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