| Primary Device ID | 00195062145261 |
| NIH Device Record Key | 03b727a6-ef49-4e1c-876c-a0e9735b1ca5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZenFlex CM |
| Version Model Number | 818-3604 |
| Company DUNS | 199354556 |
| Company Name | Kerr Corporation |
| Device Count | 6 |
| 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 | 1-800-537-7123 |
| kerrcustcare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| kerrcustcare@kavokerr.com | |
| Phone | 1-800-537-7123 |
| kerrcustcare@kavokerr.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00195062145261 [Unit of Use] |
| GS1 | 00195062145605 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00195062145261]
Moist Heat or Steam Sterilization
[00195062145261]
Moist Heat or Steam Sterilization
[00195062145261]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-27 |
| Device Publish Date | 2026-02-19 |
| 00195062145063 | .13/.04/25mm ZenFlex CM - NiTi FILE REFILL PACK |
| 00195062145056 | .13/.04/21mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145230 | .13/.06/21mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145223 | .30/.04/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145216 | .30/.04/25mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145209 | .30/.04/21mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145193 | .25/.04/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145186 | .25/.04/25mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145179 | .25/.04/21mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145162 | .20/.04/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145155 | .20/.04/25mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145148 | .20/.04/21mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145131 | .17/.04/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145124 | .17/.04/25mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145117 | .17/.04/21mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145100 | .15/.04/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145094 | .15/.04/25mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145087 | .15/.04/21mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145070 | .13/.04/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145780 | ZenFlex CM .06/25mm ASSORTED PACK US/CAN Contents: .13/.06/25mm ZenFlex CM NiTi FILE, GTIN 00195 |
| 00195062145773 | ZenFlex CM .06/21mm ASSORTED PACK US/CAN Contents: .13/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195 |
| 00195062145766 | ZenFlex CM .04/25mm ASSORTED PACK US/CAN Contents: .13/.04/25mm ZenFlex CM NiTi FILE, GTIN 00195 |
| 00195062145759 | ZenFlex CM .04/21mm ASSORTED PACK US/CAN Contents: .13/.04/21mm ZenFlex CM NiTi FILE, GTIN 00195 |
| 00195062145407 | .30/.06/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145391 | .30/.06/25mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145384 | .30/.06/21mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145377 | .25/.06/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145360 | .25/.06/25mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145353 | .25/.06/21mm ZenFlex CM iTi FILE REFILL PACK |
| 00195062145346 | .20/.06/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145339 | .20/.06/25mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145322 | .20/.06/21mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145315 | .17/.06/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145308 | .17/.06/25mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145292 | .17/.06/21mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145285 | .15/.06/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145278 | .15/.06/25mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145261 | .15/.06/21mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145254 | .13/.06/31mm ZenFlex CM NiTi FILE REFILL PACK |
| 00195062145247 | .13/.06/25mm ZenFlex CM NiTi FILE REFILL PACK |