| Primary Device ID | 10841396112888 |
| NIH Device Record Key | 442363ca-0151-4318-a659-22c6ef70c615 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Temp-Bond NE |
| Version Model Number | 31973 |
| Company DUNS | 847905890 |
| Company Name | KERR CORPORATION |
| Device Count | 50 |
| 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 | 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 |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Weight | 120 Gram |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841396112881 [Unit of Use] |
| GS1 | 10841396112888 [Primary] |
| EMA | CEMENT, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-12-15 |
| Device Publish Date | 2016-08-31 |
| 00195062152771 - ZenSeal Pro | 2026-02-18 ZenSeal Pro Bioceramic Root Canal Sealer (1 Syringe 1.5 grams, 20 Tips) |
| 00195062153099 - SimpliCore | 2026-02-18 Kerr SimpliCore Obturator for ZenFlex ONE Size Primary - 6PK |
| 00195062153105 - SimpliCore | 2026-02-18 Kerr SimpliCore Obturator for ZenFlex ONE Size Small - 6PK |
| 00195062153112 - SimpliCore | 2026-02-18 Kerr SimpliCore Obturator for ZenFlex ONE Size Medium - 6PK |
| 00195062153129 - SimpliCore | 2026-02-18 Kerr SimpliCore Obturator for ZenFlex ONE Size Large - 6PK |
| 00195062153136 - SimpliCore | 2026-02-18 Kerr SimpliCore Obturator for ZenFlex ONE Size Primary - 20PK |
| 00195062153143 - SimpliCore | 2026-02-18 Kerr SimpliCore Obturator for ZenFlex ONE Size Small - 20PK |
| 00195062153150 - SimpliCore | 2026-02-18 Kerr SimpliCore Obturator for ZenFlex ONE Size Medium - 20PK |