| Primary Device ID | E235D30BL4MN0 |
| NIH Device Record Key | 2d88b14b-d04f-48ff-a494-7c33548781e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DENTADISC |
| Version Model Number | D30BL4MN |
| Catalog Number | D30BL4MN |
| Company DUNS | 054618202 |
| Company Name | SHOFU DENTAL CORPORATION |
| 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 | true |
| 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 |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com | |
| Phone | +1(760) 736-3277 |
| customer-service@shofu.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E235D30BL4MN0 [Primary] |
| EBG | CROWN AND BRIDGE, TEMPORARY, RESIN |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-02 |
| Device Publish Date | 2026-01-25 |
| E235D35OB0 | DentaDisc CAD/CAM DISC. Dental Base. Shade Original. 98.5 x 35 mm. |
| E235D35MB0 | DentaDisc CAD/CAM DISC. Base. Shade Meharryl. 98.5 x 30 mm. |
| E235D35BLMN0 | DentaDisc CAD/CAM DISC. BL 98.5 x35mm. MN |
| E235D35BLML0 | DentaDisc CAD/CAM DISC. 98.5X35mm BL. ML |
| E235D35BL4MN0 | PORTUX CAD/CAM DISC. 98.5X35mm BL4. MN |
| E235D35BL3MN0 | DentaDisc CAD/CAM DISC. 98.5X35mm BL3. MN |
| E235D35BL3ML0 | DentaDisc CAD/CAM DISC. 98.5X35mm BL3. ML |
| E235D35BL2MN0 | DentaDisc CAD/CAM DISC. 98.5X35mm BL2. MN |
| E235D35BL1MN0 | DentaDisc CAD/CAM DISC. 98.5X35mm BL1. MN |
| E235D35B2ML0 | DentaDisc CAD/CAM DISC. 98.5X35mm B2. ML |
| E235D35B1MN0 | DentaDisc CAD/CAM DISC. 98.5X35mm B1. MN |
| E235D35B1ML0 | DentaDisc CAD/CAM DISC. 98.5X35mm B1. ML |
| E235D35A3ML0 | DentaDisc CAD/CAM DISC. 98.5X35mm A3. ML |
| E235D35A2ML0 | DentaDisc CAD/CAM DISC. 98.5X35mm A2. ML |
| E235D35A1ML0 | PORTUX CAD/CAM DISC. 98.5X35mm A1. ML |
| E235D30OB0 | DentaDisc CAD/CAM DISC. Dental Base. Shade Original. 98.5 x 30 mm. |
| E235D30D2ML0 | PORTUX CAD/CAM DISC. 98.5 x30mm D2. ML |
| E235D30C3ML0 | DentaDisc CAD/CAM DISC. 98.5 x30mm C3. ML |
| E235D30C2ML0 | PORTUX CAD/CAM DISC. 98.5 x30mm C2. ML |
| E235D30C1ML0 | PORTUX CAD/CAM DISC. 98.5 x30mm C1. ML |
| E235D30BLMN0 | DentaDisc CAD/CAM DISC. BL 98.5 x30mm. MN |
| E235D30BLML0 | DentaDisc CAD/CAM DISC. 98.5X30mm BL. ML |
| E235D30BL4MN0 | PORTUX CAD/CAM DISC. 98.5X30mm BL4. MN |
| E235D30BL3MN0 | PORTUX CAD/CAM DISC. 98.5X30mm BL3. MN |
| E235D30BL3ML0 | DentaDisc CAD/CAM DISC. 98.5X30mm BL3. ML |
| E235D30BL2MN0 | PORTUX CAD/CAM DISC. 98.5X30mm BL2. MN |
| E235D30BL1MN0 | PORTUX CAD/CAM DISC. 98.5X30mm BL1. MN |
| E235D30B2ML0 | PORTUX CAD/CAM DISC. 98.5X30mm B2. ML |
| E235D30B1ML0 | DentaDisc CAD/CAM DISC. 98.5X30mm B1. ML |
| E235D30A3ML0 | PORTUX CAD/CAM DISC. 98.5X30mm A3. ML |
| E235D30A2ML0 | PORTUX CAD/CAM DISC. 98.5X30mm A2. ML |
| E235D30A1ML0 | DentaDisc CAD/CAM DISC. 98.5X30mm A1. ML |
| E235D25OB0 | PORTUX CAD/CAM DISC. Dental Base. Shade Original. 98.5 x 25 mm. |
| E235D25D3MN0 | DentaDisc CAD/CAM DISC. 98.5 x25mm D3. MN |
| E235D25D2MN0 | DentaDisc CAD/CAM DISC. 98.5 x25mm D2. MN |
| E235D25D2ML0 | PORTUX CAD/CAM DISC. 98.5 x25mm D2. ML |
| E235D25C3ML0 | PORTUX CAD/CAM DISC. 98.5 x25mm C3. ML |
| E235D25C2MN0 | PORTUX CAD/CAM DISC. 98.5 x25mm C2. MN |
| E235D25C2ML0 | PORTUX CAD/CAM DISC. 98.5 x25mm C2. ML |
| E235D25C1MN0 | PORTUX CAD/CAM DISC. 98.5 x25mm C1. MN |
| E235D25C1ML0 | DentaDisc CAD/CAM DISC. 98.5 x25mm C1. ML |
| E235D25BLMN0 | PORTUX CAD/CAM DISC. BL 98.5 x25mm. MN |
| E235D25BLML0 | DentaDisc CAD/CAM DISC. 98.5X25mm BL. ML |
| E235D25BL4MN0 | PORTUX CAD/CAM DISC. 98.5X25mm BL4. MN |
| E235D25BL3MN0 | DentaDisc CAD/CAM DISC. 98.5X25mm BL3. MN |
| E235D25BL3ML0 | PORTUX CAD/CAM DISC. 98.5X25mm BL3. ML |
| E235D25BL2MN0 | PORTUX CAD/CAM DISC. 98.5X25mm BL2. MN |
| E235D25BL1MN0 | PORTUX CAD/CAM DISC. 98.5X25mm BL1. MN |
| E235D25B3MN0 | PORTUX CAD/CAM DISC. 98.5 x25mm B3. MN |
| E235D25B2MN0 | PORTUX CAD/CAM DISC. 98.5 x25mm B2. MN |