| Primary Device ID | 00850079280281 |
| NIH Device Record Key | 50c2139e-3f29-463b-a141-e96a0bc4c325 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SDure endo |
| Version Model Number | Sure-Cord Plus 2 |
| Company DUNS | 096955608 |
| Company Name | Hexa Dental |
| Device Count | 1 |
| 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 |
|---|---|
| GS1 | 00850079280281 [Primary] |
| MVL | Cord, Retraction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-30 |
| Device Publish Date | 2026-01-22 |
| 00850032750158 - Hexa | 2026-02-26 Hexa Temp Crown & Bridge Material 10:1 Ratio 50ml, 1 Cartridge+10Mixing Tips, A3.5, HT-0004 |
| 00850057092158 - Hexa | 2026-02-24 Hexa Temp Crown & Bridge Material 10:1 Ratio 50ml, 1 Cartridge+10Mixing Tips, A3.5, HT-0004 |
| 00850079280014 - One Plus | 2026-02-24 ONE Bite Registration Material 50ml, 100 Cartridges BULK, Regular Set |
| 00850079280069 - Turbo Edge | 2026-02-24 Hexa E-Type slow speed standard Latch head contra angle |
| 00850079280083 - Turbo edge | 2026-02-24 Hexa E-Type slow-speed Air motor only 4-Hole 25,000rpm |
| 00850079280274 - sure Endo | 2026-02-24 Knitted Retraction Cord Impregnated w/Aluminum Chloride #1 - 100 Inch (254cm) Blue |
| 00008579280274 - sure Endo | 2026-01-30 Knitted Retraction Cord Impregnated w/Aluminum Chloride #1 - 100 Inch (254cm) Blue |
| 00850079280182 - Sure Endo | 2026-01-30 Knitted Retraction Cord #000 - 100 Inch (254cm) Green |