Perfectemp® II CR1041
GUDID D813CR10410
PERFECTEMP II SYR B1
DEN-MAT HOLDINGS, LLC
Dental composite resin| Primary Device ID | D813CR10410 |
| NIH Device Record Key | eedd1c51-818a-4b66-99c3-e8d54505f332 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Perfectemp® II |
| Version Model Number | CR1041 |
| Catalog Number | CR1041 |
| 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 | |
| Phone | 1-800-433-6628 |
| info@denmat.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 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 |
| Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D813CR10410 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K013674
FDA Product Code
| EBG | Crown And Bridge, Temporary, 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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Perfectemp® II]
| D813SPD13200 | PF TMP II C&B BL2 |
| D813SPD13030 | PF TMP II C&B B1 |
| D813SPD13020 | PF TMP II C&B A3.5 |
| D813SPD13010 | PF TMP II C&B A2 |
| D813SPD13000 | PF TMP II C&B A1 |
| D813CR10430 | PERFECTEMP II SYR A2 |
| D813CR10420 | PERFECTEMP II SYR A3.5 |
| D813CR10410 | PERFECTEMP II SYR B1 |
| D813CR10400 | PERFECTEMP II SYR BL2 |
| D813CR10390 | PERFECTEMP II SYR A1 |
Trademark Results [Perfectemp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERFECTEMP 98262677 not registered Live/Pending |
FXI, Inc. 2023-11-09 |
 PERFECTEMP 97216709 not registered Live/Pending |
Splendid Footwear Co Ltd 2022-01-12 |
 PERFECTEMP 88036730 not registered Dead/Abandoned |
PPJ, LLC 2018-07-13 |
 PERFECTEMP 87346862 not registered Live/Pending |
Conair Corporation 2017-02-23 |
 PERFECTEMP 86414590 5335736 Live/Registered |
Innocor, Inc. 2014-10-03 |
 PERFECTEMP 86244220 not registered Dead/Abandoned |
Conair Corporation 2014-04-07 |
 PERFECTEMP 86147260 5050111 Live/Registered |
Welch Allyn, Inc. 2013-12-18 |
 PERFECTEMP 85426678 4289826 Live/Registered |
Conair Corporation 2011-09-20 |
 PERFECTEMP 78614376 not registered Dead/Abandoned |
FYI Enterprises, Inc. 2005-04-22 |
 PERFECTEMP 77786687 4152115 Live/Registered |
Conair Corporation 2009-07-22 |
 PERFECTEMP 77560020 not registered Dead/Abandoned |
INNOCOR, INC. 2008-09-02 |
 PERFECTEMP 77379710 3495423 Dead/Cancelled |
Junonia, Ltd. 2008-01-24 |
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