| Primary Device ID | D866MOUTHGUARDGREEN0 |
| NIH Device Record Key | 4c4c7984-f8a7-4c8c-af25-58d7660652d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KGuard Pro |
| Version Model Number | MOUTHGUARD |
| Catalog Number | MOUTHGUARD-G |
| Company DUNS | 090557638 |
| Company Name | Ortho-Tain, Inc |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D866MOUTHGUARDGREEN0 [Primary] |
| DYO | Band, Material, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-17 |
| Device Publish Date | 2025-01-09 |
| D866MOUTHGUARDPURPLE0 | MOUTHGUARD PURPLE |
| D866MOUTHGUARDPINK0 | MOUTHGUARD PINK |
| D866MOUTHGUARDORANGE0 | MOUTHGUARD ORANGE |
| D866MOUTHGUARDGREEN0 | MOUTHGUARD GREEN |
| D866MOUTHGUARDBLUE0 | MOUTHGUARD BLUE |
| D866MOUTHGUARDPK0 | MOUTHGUARD PINK |
| D866MOUTHGUARDP0 | MOUTHGUARD PURPLE |
| D866MOUTHGUARDO0 | MOUTHGUARD ORANGE |
| D866MOUTHGUARDG0 | MOUTHGUARD GREEN |
| D866MOUTHGUARDB0 | MOUTHGUARD BLUE |