| Primary Device ID | 00195062154126 |
| NIH Device Record Key | 70e194cb-c102-4e5f-91ce-da9113c4e5be |
| Commercial Distribution Discontinuation | 2025-08-08 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Kerr Restoratives |
| Version Model Number | 37328 |
| Company DUNS | 199354556 |
| Company Name | Kerr Corporation |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com | |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com | |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com | |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com | |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com | |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com | |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com | |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com | |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com | |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com | |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com | |
| Phone | 714-516-7400 |
| KerrCustCare@kerrDental.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195062154126 [Unit of Use] |
| GS1 | 00195062154188 [Primary] |
| EID | Syringe, Restorative And Impression Material |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-18 |
| Device Publish Date | 2025-08-08 |
| 00195062154164 | Kerr Intra Oral Tip Low Waste 10pk |
| 00195062154157 | Kerr Root Canal Tip Low Waste 10pk |
| 00195062154140 | NX3/Nexus RMGI 1:1 Mixing Tip (REGULAR) Low Waste 50pk |
| 00195062154133 | NX3/Nexus RMGI 1:1 Mixing Tip (WIDE) Low Waste 10pk |
| 00195062154126 | Maxcem Elite/Chroma 4:1 Mixing Tip (WIDE) Low Waste 10pk00195062154126 |
| 00195062154119 | Maxcem Elite/Chroma 4:1 Mixing Tip (REGULAR) Low Waste 50pk |