Alpha-Bond® 211.0001.002
GUDID D73521100010020
Alpha-Bond® is a 5th generation single component acetone based adhesive with a dual cure activator (purchased separately) formulated to bond to multiple substrates for both direct and indirect bonding procedures. It contains a hydrophilic monomer that allows penetration into the tubules, intertubules and peritubuler dentin. For a single step light cure adhesive, use the bottle marked adhesive. By combining the dual cure activator with the adhesive, you can confidently bond to self cure composites and areas inaccessible to light. Kit Contains: 1 x 6ml Bottle
DENTAL TECHNOLOGIES, INC.
Dentine bonding agent/set| Primary Device ID | D73521100010020 |
| NIH Device Record Key | 4297fe7a-c083-43d2-893f-4423fd5fe417 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alpha-Bond® |
| Version Model Number | 211.0001.002 |
| Catalog Number | 211.0001.002 |
| Company DUNS | 148312838 |
| Company Name | DENTAL TECHNOLOGIES, 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
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com | |
| Phone | 847-677-5500 |
| info@dentaltech.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 27 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D73521100010020 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K984503
FDA Product Code
| KLE | Agent, Tooth Bonding, 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 | 4 |
| Public Version Date | 2024-02-16 |
| Device Publish Date | 2016-09-23 |
Devices Manufactured by DENTAL TECHNOLOGIES, INC.
| D73520000000010 - ALPHA-DENT® Self Cure Bonding Adhesive | 2024-02-16 ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal visco |
| D73520000010010 - ALPHA-DENT® Self Cure Bonding Adhesive | 2024-02-16 ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal visco |
| D73520001020010 - ALPHA-DENT® Self Cure Bonding Adhesive | 2024-02-16 ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal visco |
| D73520002020010 - ALPHA-DENT® Self Cure Bonding Adhesive | 2024-02-16 ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal visco |
| D73520600000010 - ALPHA-DENT® Light Cure Bonding Adhesive | 2024-02-16 ALPHA-DENT® Light Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal visc |
| D73520600010010 - ALPHA-DENT® Light Cure Bonding Adhesive | 2024-02-16 ALPHA-DENT® Light Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal visc |
| D73520601010010 - ALPHA-DENT® Light Cure Bonding Adhesive | 2024-02-16 ALPHA-DENT® Light Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal visc |
| D73520601020010 - ALPHA-DENT® Light Cure Bonding Adhesive | 2024-02-16 ALPHA-DENT® Light Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal visc |
Trademark Results [Alpha-Bond]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALPHA-BOND 78435242 3008730 Live/Registered |
Dental Technologies, Inc. 2004-06-15 |
 ALPHA-BOND 78030291 not registered Dead/Abandoned |
Dental Technologies, Inc. 2000-10-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.