| Primary Device ID | D690TFSM250 |
| NIH Device Record Key | cbe47c06-643b-4c03-80b3-0a6b52ba8823 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXACTFLOW |
| Version Model Number | UTFSM25 |
| Catalog Number | TFSM25 |
| Company DUNS | 151760014 |
| Company Name | Ss White Burs, Inc. |
| Device Count | 3 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D690TFSM250 [Unit of Use] |
| HIBCC | D690TFSM252 [Primary] |
| EKS | FILE, PULP CANAL, ENDODONTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-25 |
| Device Publish Date | 2025-02-17 |
| D690TFSM250 | EXACTFLOW RECIPROCATING FILE SMALL 25MM - 3 PACK |
| D690TFSM210 | EXACTFLOW RECIPROCATING FILE SMALL 21MM - 3 PACK |
| D690TFPR310 | EXACTFLOW RECIPROCATING FILE PRIMARY 31MM - 3 PACK |
| D690TFPR250 | EXACTFLOW RECIPROCATING FILE PRIMARY 25MM - 3 PACK |
| D690TFMD310 | EXACTFLOW RECIPROCATING FILE MEDIUM 31MM - 3 PACK |
| D690TFMD250 | EXACTFLOW RECIPROCATING FILE MEDIUM 25MM - 3 PACK |
| D690TFMD210 | EXACTFLOW RECIPROCATING FILE MEDIUM 21MM - 3 PACK |
| D690TFLG310 | EXACTFLOW RECIPROCATING FILE LARGE 31MM - 3 PACK |
| D690TFLG250 | EXACTFLOW RECIPROCATING FILE LARGE 25MM - 3 PACK |
| D690TFLG210 | EXACTFLOW RECIPROCATING FILE LARGE 21MM - 3 PACK |
| D690TFHSM31S30 | EXACTFLOWH RECIPROCATING FILE SMALL 31MM STERILE - 3 PACK |
| D690TFHSM310 | EXACTFLOWH RECIPROCATING FILE SMALL 31MM - 3 PACK |
| D690TFHSM25S30 | EXACTFLOWH RECIPROCATING FILE SMALL 25MM STERILE - 3 PACK |
| D690TFHSM250 | EXACTFLOWH RECIPROCATING FILE SMALL 25MM - 3 PACK |
| D690TFHSM21S30 | EXACTFLOWH RECIPROCATING FILE SMALL 21MM STERILE - 3 PACK |
| D690TFHSM210 | EXACTFLOWH RECIPROCATING FILE SMALL 21MM - 3 PACK |
| D690TFHPR31S30 | EXACTFLOWH RECIPROCATING FILE PRIMARY 31MM STERILE - 3 PACK |
| D690TFHPR310 | EXACTFLOWH RECIPROCATING FILE PRIMARY 31MM - 3 PACK |
| D690TFHPR25S30 | EXACTFLOWH RECIPROCATING FILE PRIMARY 25MM STERILE - 3 PACK |
| D690TFHPR250 | EXACTFLOWH RECIPROCATING FILE PRIMARY 25MM - 3 PACK |
| D690TFHPR21S30 | EXACTFLOWH RECIPROCATING FILE PRIMARY 21MM STERILE - 3 PACK |
| D690TFHPR210 | EXACTFLOWH RECIPROCATING FILE PRIMARY 21MM - 3 PACK |
| D690TFHMD31S30 | EXACTFLOWH RECIPROCATING FILE MEDIUM 31MM STERILE - 3 PACK |
| D690TFHMD310 | EXACTFLOWH RECIPROCATING FILE MEDIUM 3MM - 3 PACK |
| D690TFHMD25S30 | EXACTFLOWH RECIPROCATING FILE MEDIUM 25MM STERILE - 3 PACK |
| D690TFHMD250 | EXACTFLOWH RECIPROCATING FILE MEDIUM 25MM - 3 PACK |
| D690TFHMD21S30 | EXACTFLOWH RECIPROCATING FILE MEDIUM 21MM STERILE - 3 PACK |
| D690TFHMD210 | EXACTFLOWH RECIPROCATING FILE MEDIUM 21MM - 3 PACK |
| D690TFHLG31S30 | EXACTFLOWH RECIPROCATING FILE LARGE 31MM STERILE - 3 PACK |
| D690TFHLG310 | EXACTFLOWH RECIPROCATING FILE LARGE 31MM - 3 PACK |
| D690TFHLG25S30 | EXACTFLOWH RECIPROCATING FILE LARGE 25MM STERILE - 3 PACK |
| D690TFHLG250 | EXACTFLOWH RECIPROCATING FILE LARGE 25MM - 3 PACK |
| D690TFHLG21S30 | EXACTFLOWH RECIPROCATING FILE LARGE 21MM STERILE - 3 PACK |
| D690TFHLG210 | EXACTFLOWH RECIPROCATING FILE LARGE 21MM - 3 PACK |
| D690TFHAS250 | EXACTFLOWH RECIPROCATING FILE SM-PR-MD-LG 25MM ASSORTED - 4 PACK |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EXACTFLOW 90307378 not registered Live/Pending |
SS White Burs, Inc. 2020-11-09 |