| Primary Device ID | B868CE1600161 |
| NIH Device Record Key | 29de335a-9f39-419a-9c32-34691b9698fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prodia Sport |
| Version Model Number | 835.010C |
| Catalog Number | CE160016 |
| Company DUNS | 054028295 |
| Company Name | ABRASIVE TECHNOLOGY, INC. |
| Device Count | 25 |
| 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 | true |
| 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 | B868CE1600160 [Unit of Use] |
| HIBCC | B868CE1600161 [Primary] |
| DZP | Instrument, Diamond, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-31 |
| Device Publish Date | 2025-03-21 |
| B868CE1600010 | Diamond Dental Bur |
| B868CE1601500 | Diamond Dental Bur |
| B868CE1601490 | Diamond Dental Bur |
| B868CE1601480 | Diamond Dental Bur |
| B868CE1601470 | Diamond Dental Bur |
| B868CE1601460 | Diamond Dental Bur |
| B868CE1601450 | Diamond Dental Bur |
| B868CE1601440 | Diamond Dental Bur |
| B868CE1601430 | Diamond Dental Bur |
| B868CE1601420 | Diamond Dental Bur |
| B868CE1601410 | Diamond Dental Bur |
| B868CE1601400 | Diamond Dental Bur |
| B868CE1601390 | Diamond Dental Bur |
| B868CE1601380 | Diamond Dental Bur |
| B868CE1601370 | Diamond Dental Bur |
| B868CE1601360 | Diamond Dental Bur |
| B868CE1601350 | Diamond Dental Bur |
| B868CE1601340 | Diamond Dental Bur |
| B868CE1601330 | Diamond Dental Bur |
| B868CE1601320 | Diamond Dental Bur |
| B868CE1601310 | Diamond Dental Bur |
| B868CE1601300 | Diamond Dental Bur |
| B868CE1601290 | Diamond Dental Bur |
| B868CE1601280 | Diamond Dental Bur |
| B868CE1601270 | Diamond Dental Bur |
| B868CE1601260 | Diamond Dental Bur |
| B868CE1601250 | Diamond Dental Bur |
| B868CE1601240 | Diamond Dental Bur |
| B868CE1601230 | Diamond Dental Bur |
| B868CE1601220 | Diamond Dental Bur |
| B868CE1601210 | Diamond Dental Bur |
| B868CE1601200 | Diamond Dental Bur |
| B868CE1601190 | Diamond Dental Bur |
| B868CE1601180 | Diamond Dental Bur |
| B868CE1601170 | Diamond Dental Bur |
| B868CE1601160 | Diamond Dental Bur |
| B868CE1601150 | Diamond Dental Bur |
| B868CE1601140 | Diamond Dental Bur |
| B868CE1601130 | Diamond Dental Bur |
| B868CE1601120 | Diamond Dental Bur |
| B868CE1601110 | Diamond Dental Bur |
| B868CE1601100 | Diamond Dental Bur |
| B868CE1601090 | Diamond Dental Bur |
| B868CE1601080 | Diamond Dental Bur |
| B868CE1601070 | Diamond Dental Bur |
| B868CE1601060 | Diamond Dental Bur |
| B868CE1601050 | Diamond Dental Bur |
| B868CE1601040 | Diamond Dental Bur |
| B868CE1601030 | Diamond Dental Bur |
| B868CE1601020 | Diamond Dental Bur |