| Primary Device ID | D080XXPMD985M35XB10 | 
| NIH Device Record Key | d556d4a6-da25-4a2b-b62e-5288f19ee8ef | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | PMMA DISK | 
| Version Model Number | 1PC,35MM*98.5MM,B1 | 
| 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 | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false |