Clear Bite™ SPD1104
GUDID D813SPD11040
CLEARBITE CART SET MINT
DEN-MAT HOLDINGS, LLC
Silicone dental impression material| Primary Device ID | D813SPD11040 |
| NIH Device Record Key | 9968e120-c3e5-43c7-a2a7-faf09749c374 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clear Bite™ |
| Version Model Number | SPD1104 |
| Catalog Number | SPD1104 |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to direct sunlight |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 78 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D813SPD11040 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K030776
FDA Product Code
| ELW | Material, Impression |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
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Trademark Results [Clear Bite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEAR BITE 77002533 not registered Dead/Abandoned |
Remarkable Dental Products Inc. 2006-09-19 |
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