ALPHA-DENT® One Step Primer 209.0101.001
GUDID D73520901010010
ALPHA-DENT® One Step Primer is part of the Paste-Primer system formulated to bond to metal, ceramic and plastic brackets. Kit Contains: 1 x 12ml Primer
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 | D73520901010010 |
| NIH Device Record Key | b09d529c-5846-4f52-b6a4-734fe503396e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALPHA-DENT® One Step Primer |
| Version Model Number | 209.0101.001 |
| Catalog Number | 209.0101.001 |
| 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 | 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 | D73520901010010 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K921044
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 | 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-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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