| Primary Device ID | D716053250350 |
| NIH Device Record Key | 4fdc07a5-a233-4d4c-9f00-aac198f08e0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endodontic Hand Instruments |
| Version Model Number | 5325020 |
| Catalog Number | 5325035 |
| Company DUNS | 942778564 |
| Company Name | TULSA DENTAL PRODUCTS LLC |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D716053250350 [Unit of Use] |
| HIBCC | D716053250351 [Primary] |
| EKP | REAMER, PULP CANAL, ENDODONTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2022-11-19 |
| D7166687421 | Unifile hand file Maillefer North America |
| D7166687411 | Unifile hand file Maillefer North America |
| D7166687341 | Unifile hand file Maillefer North America |
| D7166687331 | Unifile hand file Maillefer North America |
| D7166687321 | Unifile hand file Maillefer North America |
| D7166687311 | Unifile hand file Maillefer North America |
| D7166687301 | Unifile hand file Maillefer North America |
| D7166687291 | Unifile hand file Maillefer North America |
| D7166687281 | Unifile hand file Maillefer North America |
| D7166687271 | Unifile hand file Maillefer North America |
| D7166687261 | Unifile hand file Maillefer North America |
| D7166687251 | Unifile hand file Maillefer North America |
| D7166687241 | Unifile hand file Maillefer North America |
| D7166687231 | Unifile hand file Maillefer North America |
| D7166687221 | Unifile hand file Maillefer North America |
| D7166687201 | Unifile hand file Maillefer North America |
| D7166687191 | Unifile hand file Maillefer North America |
| D7166687121 | Unifile hand file Maillefer North America |
| D7166687111 | Unifile hand file Maillefer North America |
| D7166687101 | Unifile hand file Maillefer North America |
| D7166687091 | Unifile hand file Maillefer North America |
| D7166687081 | Unifile hand file Maillefer North America |
| D7166687071 | Unifile hand file Maillefer North America |
| D7166687061 | Unifile hand file Maillefer North America |
| D7166687051 | Unifile hand file Maillefer North America |
| D7166687041 | Unifile hand file Maillefer North America |
| D7166687031 | Unifile hand file Maillefer North America |
| D7166687021 | Unifile hand file Maillefer North America |
| D7166687011 | Unifile hand file Maillefer North America |
| D7166687001 | Unifile hand file Maillefer North America |
| D71668480310 | Ready•Steel K-FILE 080 31MM |
| D71668480250 | Ready•Steel K-FILE 080 25MM |
| D71668480210 | Ready•Steel K-FILE 080 21MM |
| D71668470310 | Ready•Steel K-FILE 070 31MM |
| D71668470250 | Ready•Steel K-FILE 070 25MM |
| D71668470210 | Ready•Steel K-FILE 070 21MM |
| D71668460310 | Ready•Steel K-FILE 060 31MM |
| D71668460250 | Ready•Steel K-FILE 060 25MM |
| D71668460210 | Ready•Steel K-FILE 060 21MM |
| D71668455310 | Ready•Steel K-FILE 055 31MM |
| D71668455250 | Ready•Steel K-FILE 055 25MM |
| D71668455210 | Ready•Steel K-FILE 055 21MM |
| D71668450310 | Ready•Steel K-FILE 050 31MM |
| D71668450250 | Ready•Steel K-FILE 050 25MM |
| D71668450210 | Ready•Steel K-FILE 050 21MM |
| D71668445310 | Ready•Steel K-FILE 045 31MM |
| D71668445250 | Ready•Steel K-FILE 045 25MM |
| D71668445210 | Ready•Steel K-FILE 045 21MM |
| D71668440310 | Ready•Steel K-FILE 040 31MM |
| D71668440290 | Ready•Steel K-FILE 45-80 31MM |