BracePaste 020-033120
GUDID 00190746134388
ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE SYRINGE 2/PK
AMERICAN ORTHODONTICS CORPORATION
Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive| Primary Device ID | 00190746134388 |
| NIH Device Record Key | 1cecba9f-8b58-42a4-8883-dd6359a83f50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BracePaste |
| Version Model Number | 020-033120 |
| Catalog Number | 020-033120 |
| Company DUNS | 044668515 |
| Company Name | AMERICAN ORTHODONTICS CORPORATION |
| 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 | false |
| 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
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com | |
| Phone | +1(800)558-7687 |
| info@americanortho.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Away from Light |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190746134388 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160782
FDA Product Code
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-14 |
| Device Publish Date | 2020-10-06 |
On-Brand Devices [BracePaste]
| 00190746034855 | ADHESIVE BRACEPASTE MEDIUM VISCOSITY ADHESIVE, 20 CARPULES (6G) |
| 00190746034848 | ADHESIVE BRACEPASTE MEDIUM VISCOSITY ADHESIVE, 1 SYRINGE (4G) |
| 00190746034831 | ADHESIVE BRACEPASTE MEDIUM VISCOSITY ADHESIVE, 4 SYRINGES (16G) |
| 00190746034824 | ADHESIVE BRACEPASTE MEDIUM VISCOSITY ADHESIVE, 2 SYRINGES (8G) |
| 00190746150821 | ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE CARPULES 20/PK |
| 00190746150814 | ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE SYRINGE 4/PK |
| 00190746150807 | ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE SYRINGE 1/PK |
| 00190746134388 | ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE SYRINGE 2/PK |
| 00190746059322 | ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE CARPULES 20/PK |
| 00190746059292 | ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE SYRINGE 4/PK |
| 00190746059285 | ADHESIVE BRACEPASTE ADHESIVE COLOR CHANGE SYRINGE 1/PK |
| 00190746059223 | ADHESIVE BRACEPASTE MEDIUM VISCOSITY ADHESIVE, 20 CARPULES (6G) |
| 00190746059216 | ADHESIVE BRACEPASTE MEDIUM VISCOSITY ADHESIVE, 1 SYRINGE (4G) |
| 00190746059209 | ADHESIVE BRACEPASTE MEDIUM VISCOSITY ADHESIVE, 4 SYRINGES (16G) |
| 00190746059193 | ADHESIVE BRACEPASTE MEDIUM VISCOSITY ADHESIVE, 2 SYRINGES (8G) |
Trademark Results [BracePaste]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRACEPASTE 87507504 5450114 Live/Registered |
American Orthodontics Corporation 2017-06-27 |
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