| Primary Device ID | D716KRS008250 |
| NIH Device Record Key | 9b6dc436-733e-4023-92b0-255dad483a15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Endodontic Hand Instrument |
| Version Model Number | KRS00825 |
| Catalog Number | KRS00825 |
| 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 | true |
| 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 | D716KRS008250 [Unit of Use] |
| HIBCC | D716KRS008251 [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 | 2022-11-03 |
| Device Publish Date | 2022-10-26 |
| D716SSK037310 | FLEXSSK: 037.5 31MM LEXICON |
| D716SSK037250 | FLEXSSK: 037.5 25MM LEXICON |
| D716SSK037210 | FLEXSSK: 037.5 21MM LEXICON |
| D716SSK032310 | FLEXSSK: 032.5 31MM LEXICON |
| D716SSK032250 | FLEXSSK: 032.5 25MM LEXICON |
| D716SSK032210 | FLEXSSK: 032.5 21MM LEXICON |
| D716SSK027310 | FLEXSSK: 027.5 31MM LEXICON |
| D716SSK027250 | FLEXSSK: 027.5 25MM LEXICON |
| D716SSK027210 | FLEXSSK: 027.5 21MM LEXICON |
| D716SSK022310 | FLEXSSK: 022.5 31MM LEXICON |
| D716SSK022250 | FLEXSSK: 022.5 25MM LEXICON |
| D716SSK022210 | FLEXSSK: 022.5 21MM LEXICON |
| D716KRS1540310 | K REAMER: 15-40 31MM LEXICON |
| D716KRS1540250 | K REAMER: 15-40 25MM LEXICON |
| D716KRS1540210 | K REAMER: 15-40 21MM LEXICON |
| D716KRS040310 | K REAMER: 040 31MM LEXICON |
| D716KRS040250 | K REAMER: 040 25MM LEXICON |
| D716KRS040210 | K REAMER: 040 21MM LEXICON |
| D716KRS035310 | K REAMER: 035 31MM LEXICON |
| D716KRS035250 | K REAMER: 035 25MM LEXICON |
| D716KRS035210 | K REAMER: 035 21MM LEXICON |
| D716KRS030310 | K REAMER: 030 31MM LEXICON |
| D716KRS030250 | K REAMER: 030 25MM LEXICON |
| D716KRS030210 | K REAMER: 030 21MM LEXICON |
| D716KRS025310 | K REAMER: 025 31MM LEXICON |
| D716KRS025250 | K REAMER: 025 25MM LEXICON |
| D716KRS025210 | K REAMER: 025 21MM LEXICON |
| D716KRS020310 | K REAMER: 020 31MM LEXICON |
| D716KRS020250 | K REAMER: 020 25MM LEXICON |
| D716KRS020210 | K REAMER: 020 21MM LEXICON |
| D716KRS015310 | K REAMER: 015 31MM LEXICON |
| D716KRS015250 | K REAMER: 015 25MM LEXICON |
| D716KRS015210 | K REAMER: 015 21MM LEXICON |
| D716KRS010310 | K REAMER: 010 31MM LEXICON |
| D716KRS010250 | K REAMER: 010 25MM LEXICON |
| D716KRS010210 | K REAMER: 010 21MM LEXICON |
| D716KRS008310 | K REAMER: 008 31MM LEXICON |
| D716KRS008250 | K REAMER: 008 25MM LEXICON |
| D716KRS008210 | K REAMER: 008 21MM LEXICON |
| D716HFS90140250 | HEDSTROM: 90-140 25MM LEXICON |
| D716HFS90140210 | HEDSTROM: 90-140 21MM LEXICON |
| D716HFS4580250 | HEDSTROM: 45-80 25MM LEXICON |
| D716HFS4580210 | HEDSTROM: 45-80 21MM LEXICON |
| D716HFS1540250 | HEDSTROM: 15-40 25MM LEXICON |
| D716HFS1540210 | HEDSTROM: 15-40 21MM LEXICON |
| D716HFS080250 | HEDSTROM: 080 25MM LEXICON |
| D716HFS080210 | HEDSTROM: 080 21MM LEXICON |
| D716HFS070250 | HEDSTROM: 070 25MM LEXICON |
| D716HFS070210 | HEDSTROM: 070 21MM LEXICON |
| D716HFS060250 | HEDSTROM: 060 25MM LEXICON |