| Primary Device ID | D080XXBTCX1KGXXLFA0 |
| NIH Device Record Key | 0d1805c2-aeb3-42cb-b39a-76ca07fe536f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BASIS TWIN CURE |
| Version Model Number | 1KG,LF α |
| Company DUNS | 693430001 |
| Company Name | YAMAHACHI DENTAL MFG.,CO. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D080XXBTCX1KGXXLFA0 [Primary] |
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-10 |
| Device Publish Date | 2023-10-02 |
| 04582275711127 | 1kg, V PINK |
| 04582275711066 | 1kg, O PINK |
| 04582275711035 | 1kg, LF PINK |
| 04582275711028 | 500ml |
| 04582594040830 | 40g, O PINK |
| D080XXBTCX40GXXOPN0 | 40G,O PINK |
| D080XXBTCX1KGXXVPN0 | 1KG,V PINK |
| D080XXBTCX1KGXXOPN0 | 1KG,O PINK |
| D080XXBTCX1KGXXLFP0 | 1KG,LF PINK |
| D080XXBTC500MXXXXX0 | 500ML |
| D080XXBTCX40GXXVPN0 | 40G,V PINK |
| D080XXBTCX40GXXLFP0 | 40G,LF PINK |
| D080XXBTCX40GXXLFA0 | 40G,LF α |
| D080XXBTCX1KGXXLFA0 | 1KG,LF α |
| D080XXBTCX17LXXXXX0 | 17L |
| D080XXBTC4020XXVPN0 | 40G*20ML,V PINK |
| D080XXBTC4020XXOPN0 | 40G*20ML,O PINK |
| D080XXBTC4020XXLFP0 | 40G*20ML,LF PINK |
| D080XXBTC4020XXLFA0 | 40G*20ML,LF α |
| D080XXBTC20MLXXXXX0 | 20ML |