| Primary Device ID | D080SDGNS17PCSX17C0 |
| NIH Device Record Key | 423d7a92-fb34-4b92-8f20-c97967bb73fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SHADE GUIDE NS |
| Version Model Number | SHADE GUIDE NS,17PCS,17C |
| 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 | false |
| 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 | D080SDGNS17PCSX17C0 [Primary] |
| ELM | Denture, Plastic, Teeth |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-03 |
| Device Publish Date | 2025-11-25 |
| D080SDGNS17PCSX17C0 - SHADE GUIDE NS | 2025-12-03 |
| D080SDGNS17PCSX17C0 - SHADE GUIDE NS | 2025-12-03 |
| D080XXPMD985M18VPN0 - PMMA DISK | 2025-08-11 |
| D080XXPMD101M13PV80 - PMMA DISK | 2025-02-11 |
| D080XXPMD101M20PV80 - PMMA DISK | 2025-02-11 |
| D080XXPMD95MM20PV80 - PMMA DISK | 2025-02-11 |
| D080XXPMD95MM22PV80 - PMMA DISK | 2025-02-11 |
| D080XXPMD95MM25PV80 - PMMA DISK | 2025-02-11 |
| D080XXPMD95MM30PV80 - PMMA DISK | 2025-02-11 |