ALPHA-DENT® Self Cure Bonding Adhesive 200.0001.001
GUDID D73520000010010
ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to dentin and enamel. The ideal viscosity allows the material to penetrate into microtubules to enhance mechanical adhesion. Kit Contains: 3ml Base Adhesive, 3ml Catalyst Adhesive, 2 x 4g Etch Gel Syringes, Mixing Pad
DENTAL TECHNOLOGIES, INC.
Dentine bonding agent/set| Primary Device ID | D73520000010010 |
| NIH Device Record Key | e9348d49-fc9e-42fa-99fd-3b9776d42fe0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALPHA-DENT® Self Cure Bonding Adhesive |
| Version Model Number | 200.0001.001 |
| Catalog Number | 200.0001.001 |
| 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 | true |
| 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 | D73520000010010 [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 |
On-Brand Devices [ALPHA-DENT® Self Cure Bonding Adhesive]
| D73520002020010 | ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to den |
| D73520001020010 | ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to den |
| D73520000010010 | ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to den |
| D73520000000010 | ALPHA-DENT® Self Cure Bonding Adhesive is designed for bonding composite resin materials to den |
Trademark Results [ALPHA-DENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALPHA-DENT 98457490 not registered Live/Pending |
Dental Technologies, Inc. 2024-03-19 |
 ALPHA-DENT 76597959 2988715 Dead/Cancelled |
Dental Technologies, Inc. 2004-06-18 |
 ALPHA-DENT 73261401 1244103 Dead/Cancelled |
William Getz International, Inc. 1980-05-09 |
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