BracePaste 020-026879
GUDID 00190746034848
ADHESIVE BRACEPASTE MEDIUM VISCOSITY ADHESIVE, 1 SYRINGE (4G)
AMERICAN ORTHODONTICS CORPORATION
Orthodontic bracket adhesive| Primary Device ID | 00190746034848 |
| NIH Device Record Key | 05da969c-e9af-4a6e-947c-a5842805e65f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BracePaste |
| Version Model Number | 020-026879 |
| Catalog Number | 020-026879 |
| 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 | true |
| 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
| Phone | 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 |
| 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 | 00190746034848 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-22 |
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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