| Primary Device ID | 04582275711035 | 
| NIH Device Record Key | 5892c454-33dd-468d-9cf1-a582606e5981 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Basis Twin Cure | 
| Version Model Number | 1kg, LF PINK | 
| 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 | 
|---|---|
| GS1 | 04582275711035 [Primary] | 
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2018-07-06 | 
| Device Publish Date | 2018-02-03 | 
| 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 |