| Primary Device ID | D080XXWAD95MM25BLU0 |
| NIH Device Record Key | 1eb34d97-6315-4b0c-8ed6-7f679112860c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WAX DISK |
| Version Model Number | 1PC,25MM*95MM,BLUE |
| Company DUNS | 693430001 |
| Company Name | YAMAHACHI DENTAL MFG.,CO. |
| 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 | 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 | D080XXWAD95MM25BLU0 [Primary] |
| EBH | Material, Impression Tray, Resin |
| EGD | Wax, Dental, Intraoral |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-13 |
| Device Publish Date | 2023-10-05 |
| D080XXWAD985M30IVO0 | 1PC,30MM*98.5MM,IVORY |
| D080XXWAD985M30GRE0 | 1PC,30MM*98.5MM,GREEN |
| D080XXWAD985M30BLU0 | 1PC,30MM*98.5MM,BLUE |
| D080XXWAD985M25IVO0 | 1PC,25MM*98.5MM,IVORY |
| D080XXWAD985M25GRE0 | 1PC,25MM*98.5MM,GREEN |
| D080XXWAD985M25BLU0 | 1PC,25MM*98.5MM,BLUE |
| D080XXWAD985M22IVO0 | 1PC,22MM*98.5MM,IVORY |
| D080XXWAD985M22GRE0 | 1PC,22MM*98.5MM,GREEN |
| D080XXWAD985M22BLU0 | 1PC,22MM*98.5MM,BLUE |
| D080XXWAD985M20IVO0 | 1PC,20MM*98.5MM,IVORY |
| D080XXWAD985M20GRE0 | 1PC,20MM*98.5MM,GREEN |
| D080XXWAD985M20BLU0 | 1PC,20MM*98.5MM,BLUE |
| D080XXWAD985M18IVO0 | 1PC,18MM*98.5MM,IVORY |
| D080XXWAD985M18GRE0 | 1PC,18MM*98.5MM,GREEN |
| D080XXWAD985M18BLU0 | 1PC,18MM*98.5MM,BLUE |
| D080XXWAD985M16IVO0 | 1PC,16MM*98.5MM,IVORY |
| D080XXWAD985M16GRE0 | 1PC,16MM*98.5MM,GREEN |
| D080XXWAD985M16BLU0 | 1PC,16MM*98.5MM,BLUE |
| D080XXWAD985M15IVO0 | 1PC,15MM*98.5MM,IVORY |
| D080XXWAD985M15GRE0 | 1PC,15MM*98.5MM,GREEN |
| D080XXWAD985M15BLU0 | 1PC,15MM*98.5MM,BLUE |
| D080XXWAD985M14IVO0 | 1PC,14MM*98.5MM,IVORY |
| D080XXWAD985M14GRE0 | 1PC,14MM*98.5MM,GREEN |
| D080XXWAD985M14BLU0 | 1PC,14MM*98.5MM,BLUE |
| D080XXWAD985M12IVO0 | 1PC,12MM*98.5MM,IVORY |
| D080XXWAD985M12GRE0 | 1PC,12MM*98.5MM,GREEN |
| D080XXWAD985M12BLU0 | 1PC,12MM*98.5MM,BLUE |
| D080XXWAD985M10IVO0 | 1PC,10MM*98.5MM,IVORY |
| D080XXWAD985M10GRE0 | 1PC,10MM*98.5MM,GREEN |
| D080XXWAD985M10BLU0 | 1PC,10MM*98.5MM,BLUE |
| D080XXWAD95MM25IVO0 | 1PC,25MM*95MM,IVORY |
| D080XXWAD95MM25GRE0 | 1PC,25MM*95MM,GREEN |
| D080XXWAD95MM25BLU0 | 1PC,25MM*95MM,BLUE |
| D080XXWAD95MM22IVO0 | 1PC,22MM*95MM,IVORY |
| D080XXWAD95MM22GRE0 | 1PC,22MM*95MM,GREEN |
| D080XXWAD95MM22BLU0 | 1PC,22MM*95MM,BLUE |
| D080XXWAD95MM20IVO0 | 1PC,20MM*95MM,IVORY |
| D080XXWAD95MM20GRE0 | 1PC,20MM*95MM,GREEN |
| D080XXWAD95MM20BLU0 | 1PC,20MM*95MM,BLUE |
| D080XXWAD95MM18IVO0 | 1PC,18MM*95MM,IVORY |
| D080XXWAD95MM18GRE0 | 1PC,18MM*95MM,GREEN |
| D080XXWAD95MM18BLU0 | 1PC,18MM*95MM,BLUE |
| D080XXWAD95MM16IVO0 | 1PC,16MM*95MM,IVORY |
| D080XXWAD95MM16GRE0 | 1PC,16MM*95MM,GREEN |
| D080XXWAD95MM16BLU0 | 1PC,16MM*95MM,BLUE |
| D080XXWAD95MM15IVO0 | 1PC,15MM*95MM,IVORY |
| D080XXWAD95MM15GRE0 | 1PC,15MM*95MM,GREEN |
| D080XXWAD95MM15BLU0 | 1PC,15MM*95MM,BLUE |
| D080XXWAD95MM14IVO0 | 1PC,14MM*95MM,IVORY |
| D080XXWAD95MM14GRE0 | 1PC,14MM*95MM,GREEN |