Stick 900823
GUDID J0229008231
Stick® RESIN (5 mL) bottle.
Gc America Inc.
Dentine bonding agent/set| Primary Device ID | J0229008231 |
| NIH Device Record Key | 9cdc0cae-5dce-4f6a-b7a2-e566f156c7b2 |
| Commercial Distribution Discontinuation | 2021-10-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stick |
| Version Model Number | 900823 |
| Catalog Number | 900823 |
| Company DUNS | 005473608 |
| Company Name | Gc America 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 | false |
| 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
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J0229008231 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K953476
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 | 2021-09-13 |
| Device Publish Date | 2016-08-01 |
Devices Manufactured by Gc America Inc.
| 10386040015264 - GC Fuji ORTHO™ | 2024-03-21 |
| 10386040015271 - GC Fuji ORTHO™ | 2024-03-21 |
| 10386040015288 - GC Fuji Ortho™ | 2024-03-21 |
| 20386040015247 - Foundation | 2024-03-20 Collagen-Based Bone Filling Augmentation Material |
| 20386040015254 - Foundation | 2024-03-20 Collagen-Based Bone Filling Augmentation Material |
| 10386040015233 - GC Tooth Mousse | 2024-03-15 GC Tooth Mousse Plus |
| D0470000631 - UniFil® | 2024-02-16 UniFil® 6 mL self-etching primer liquid |
| D0470000641 - UniFil® | 2024-02-16 UniFil® 6 mL bonding agent liquid |
Trademark Results [Stick]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STICK 88665433 not registered Live/Pending |
Lafayette Bay Products, LLC 2019-10-23 |
 STICK 88456930 not registered Live/Pending |
Lafayette Bay Products, LLC 2019-06-03 |
 STICK 87243133 not registered Dead/Abandoned |
Blot, Inc. 2016-11-21 |
 STICK 86973020 5221078 Live/Registered |
Nicolaudie America, Inc. 2016-04-12 |
 STICK 85241326 4381881 Live/Registered |
STICK SPORTS LIMITED 2011-02-14 |
 STICK 79253751 5802944 Live/Registered |
DAVOS S.p.A. 2018-12-18 |
 STICK 79146839 4797188 Live/Registered |
Stick Sports Limited 2013-11-07 |
 STICK 78870800 3339575 Dead/Cancelled |
Metzner, Jeffrey 2006-04-27 |
 STICK 78865942 3405462 Dead/Cancelled |
Metzner, Jeffrey 2006-04-20 |
 STICK 78185408 not registered Dead/Abandoned |
Homelite Technologies, Ltd. 2002-11-15 |
 STICK 77494703 not registered Dead/Abandoned |
David M. Gleason 2008-06-09 |
 STICK 77375043 not registered Dead/Abandoned |
American Pioneer Powder, Inc. 2008-01-18 |
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