| Primary Device ID | B868CEZT000140 |
| NIH Device Record Key | d849f60b-65d7-4fcb-a8ac-7b23a25c4db6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prodia Z-series |
| Version Model Number | 862.012ZF |
| Catalog Number | CEZT00014 |
| Company DUNS | 054028295 |
| Company Name | ABRASIVE TECHNOLOGY, INC. |
| Device Count | 5 |
| DM Exempt | true |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B868CEZT000140 [Unit of Use] |
| HIBCC | B868CEZT000141 [Primary] |
| DZP | Instrument, Diamond, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
[B868CEZT000140]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-22 |
| Device Publish Date | 2025-04-14 |
| B868CEZT000260 | Diamond Dental Bur |
| B868CEZT000210 | Diamond Dental Bur |
| B868CEZT000180 | Diamond Dental Bur |
| B868CEZT000130 | Diamond Dental Bur |
| B868CEZT000100 | Diamond Dental Bur |
| B868CEZT000280 | Diamond Dental Bur |
| B868CEZT000250 | Diamond Dental Bur |
| B868CEZT000240 | Diamond Dental Bur |
| B868CEZT000230 | Diamond Dental Bur |
| B868CEZT000220 | Diamond Dental Bur |
| B868CEZT000200 | Diamond Dental Bur |
| B868CEZT000190 | Diamond Dental Bur |
| B868CEZT000170 | Diamond Dental Bur |
| B868CEZT000160 | Diamond Dental Bur |
| B868CEZT000150 | Diamond Dental Bur |
| B868CEZT000140 | Diamond Dental Bur |
| B868CEZT000120 | Diamond Dental Bur |
| B868CEZT000110 | Diamond Dental Bur |
| B868CEZT000090 | Diamond Dental Bur |
| B868CEZTS00260 | Diamond Dental Bur |
| B868CEZTS00250 | Diamond Dental Bur |
| B868CEZTS00240 | Diamond Dental Bur |
| B868CEZTS00180 | Diamond Dental Bur |