everStick® 900827
GUDID J0229008271
everStick® POST Intro Kit (5 x 0.9 posts, 5 x 1.2 posts and 5 x 1.5 posts and 1 x 5 mL of StickRESIN bottle)
Gc America Inc.
Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made Root canal post, custom-made| Primary Device ID | J0229008271 |
| NIH Device Record Key | acbcb257-beba-47ab-a19b-2e0b3796cb85 |
| Commercial Distribution Discontinuation | 2021-10-01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | everStick® |
| Version Model Number | 900827 |
| Catalog Number | 900827 |
| 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 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 35 Degrees Fahrenheit and 46 Degrees Fahrenheit |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J0229008271 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030820
FDA Product Code
| ELR | POST, ROOT CANAL |
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 |
On-Brand Devices [everStick®]
| J0229008221 | everStick® PERIO 2 x 12 cm fiber bundles |
| J0229008271 | everStick® POST Intro Kit (5 x 0.9 posts, 5 x 1.2 posts and 5 x 1.5 posts and 1 x 5 mL of Stick |
| J0229008191 | everSticks Starter Kit |
| 15400556008710 | everStick® 1 x 8 cm fiber bundle (everStickC&B) |
| 15400556008703 | everStick® C&B 2 x 12 cm fiber bundle |
| 15400556008697 | everStick® PERIO 1 x 8 cm fiber bundle |
| 15400556008680 | everStick® ORTHO 2 x 12 cm fiber bundles |
| 15400556008673 | everStick® POST 5 x 2 post 1.5 |
| 15400556008666 | everStick® POST 5x2 posts 1.2 |
| 15400556008659 | everStick® POST 5 x 2 posts 0.9 |
| 15400556008598 | everStick® PERIO 2 x 12 cm fiber bundles |
| 15400556008550 | everStick® NET 1 x 30 cm2 fiber mesh |
Trademark Results [everStick]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVERSTICK 76278417 2879900 Live/Registered |
Stick Tech Oy 2001-06-29 |
 EVERSTICK 71565763 0525271 Dead/Expired |
EVERSTICK ANCHOR COMPANY 1948-09-24 |
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