Permlastic
GUDID 10841396118750
Impression material, bulk package, regular bodied (base and catalyst)
Kerr Corporation
Polysulfide dental impression material| Primary Device ID | 10841396118750 |
| NIH Device Record Key | cc615c62-9582-41c5-b2c8-1e1109596f0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Permlastic |
| Version Model Number | 16411 |
| Company DUNS | 199354556 |
| Company Name | Kerr Corporation |
| 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 | 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 | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com | |
| Phone | 1-800-5377123 |
| customercare@kavokerrgroup.com |
Device Dimensions
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
| Weight | 2760 Gram |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 28 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841396118750 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K003650
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 | 2 |
| Public Version Date | 2024-11-04 |
| Device Publish Date | 2021-04-20 |
On-Brand Devices [Permlastic]
| 10841396118767 | Impression material, bulk package, light bodied (base and catalyst) |
| 10841396118750 | Impression material, bulk package, regular bodied (base and catalyst) |
| 10841396118743 | Impression material, bulk package, heavy bodied (base and catalyst) |
| 00841396118722 | Impression material, standard package, light bodied (base and catalyst) |
| 00841396118715 | Impression material, standard package, regular bodied (base and catalyst) |
| 00841396118708 | Impression material, standard package, heavy bodied (base and catalyst) |
| 00841396118685 | Impression material catalyst, light bodied |
| 00841396118678 | Impression material base, light bodied |
| 00841396118661 | Impression material catalyst, heavy bodied |
| 00841396118654 | Impression material base, heavy bodied |
| 00841396118647 | Impression material catalyst, regular bodied |
| 00841396118630 | Impression material base, regular bodied |
Trademark Results [Permlastic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERMLASTIC 71661279 0597178 Live/Registered |
KERR MANUFACTURING COMPANY 1954-02-18 |
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