ZenSeal
GUDID 00195062076329
Bio Ceramic Root Canal Sealer Syringe and (2x10Pk) Disposable Tips
Kerr Corporation
Hygroscopic dental cement| Primary Device ID | 00195062076329 |
| NIH Device Record Key | c0a37a93-7746-46c6-acfd-5d4940f990f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZenSeal |
| Version Model Number | 825-9501 |
| Company DUNS | 199354556 |
| Company Name | Kerr Corporation |
| Device Count | 3 |
| 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 | true |
| 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 | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| KerrCustCare@kavokerr.com |
Device Dimensions
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
| Weight | 2 Gram |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
| Special Storage Condition, Specify | Between 0 and 0 *15°C (59°F) - 25°C (77°F) |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195062076329 [Unit of Use] |
| GS1 | 00195062076381 [Primary] |
FDA Product Code
| KIF | Resin, Root Canal Filling |
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 | 2023-09-11 |
| Device Publish Date | 2023-09-01 |
On-Brand Devices [ZenSeal]
| 00195062076329 | Bio Ceramic Root Canal Sealer Syringe and (2x10Pk) Disposable Tips |
| 00195062076367 | Disposable Tips 10 PK |
Trademark Results [ZenSeal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ZENSEAL 98086308 not registered Live/Pending |
Kerr Corporation 2023-07-14 |
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