MPa Universal™ Light-Cure Universal Adhesive 5mL Bottle 267001
GUDID 00359883006563
Dentine bonding agent/set
DEN-MAT HOLDINGS, LLC
Dentine bonding agent/set| Primary Device ID | 00359883006563 |
| NIH Device Record Key | 3c600de0-5b1f-4c08-a876-24b5dc9762f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MPa Universal™ Light-Cure Universal Adhesive 5mL Bottle |
| Version Model Number | 267001 |
| Catalog Number | 267001 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| 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 | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com | |
| Phone | +1(800)433-6628 |
| info@denmat.com |
Device Dimensions
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. Avoid storage in direct sunlight. |
| Storage Environment Temperature | Between 0 and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00359883006563 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042614
FDA Product Code
| KLE | AGENT, TOOTH BONDING, RESIN |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-20 |
| Device Publish Date | 2025-03-12 |
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| 00359883006273 - Final Shine Cotton Polishing Wheel 50-Pack | 2025-03-21 Wheel, Polishing Agent |
| 00359883006501 - Clinician's Choice® G5 Sample Pack | 2025-03-21 Dental coating, tooth-desensitizing, professional |
| 00359883000608 - PowerMix™ Automatic Impression Material Dispenser | 2025-03-20 Two-component dental material applicator, electric |
| 00359883000615 - PowerMix™ Dynamic Mixing Tips | 2025-03-20 Dental material mixing nozzle, non-sterile |
| 00359883000882 - Dual-Force™ Sectional Matrix System Pre-Molar Rings Orange | 2025-03-20 Device to engage the matrices and separate teeth |
Trademark Results [MPa Universal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MPA UNIVERSAL 97441180 not registered Live/Pending |
CLINICIAN'S CHOICE DENTAL PRODUCTS INC. 2022-06-02 |
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