Alpha-Bond® SE 211.0401.002
GUDID D73521104010020
Alpha-Bond® SE is a 7th generation self-etch adhesive formulated to bond to multiple substrates for both direct and indirect bonding procedures. It's a universal adhesive that has the bond strength and durability of a total-etch adhesive while eliminating the etching step. Kit Contains: 1 x 5ml Bottle
DENTAL TECHNOLOGIES, INC.
Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set| Primary Device ID | D73521104010020 |
| NIH Device Record Key | b467dae2-070b-4105-842d-cbc93e81aae5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alpha-Bond® SE |
| Version Model Number | 211.0401.002 |
| Catalog Number | 211.0401.002 |
| 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 | D73521104010020 [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 |
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