GBLOCK
GUDID D8130303761100
GBLOCK DESENSITIZER 10ml
DEN-MAT HOLDINGS, LLC
Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional Dental coating, tooth-desensitizing, professional| Primary Device ID | D8130303761100 |
| NIH Device Record Key | 496bf0e8-cd66-4146-8fb7-e1d4f14fb43a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GBLOCK |
| Version Model Number | 030376110 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8130303761100 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K222357
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 | 2023-03-14 |
| Device Publish Date | 2023-03-06 |
On-Brand Devices [GBLOCK]
| D8130303761100 | GBLOCK DESENSITIZER 10ml |
| D8130303761050 | GBLOCK DESENSITIZER 5ml |
Trademark Results [GBLOCK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GBLOCK 88297241 not registered Live/Pending |
a. Goolsby Testing, Inc. 2019-02-11 |
 GBLOCK 88295220 not registered Live/Pending |
Goolsby Testing, Inc. 2019-02-09 |
 GBLOCK 77049771 3285165 Dead/Cancelled |
Building Alternatives, Inc. 2006-11-22 |
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