| Primary Device ID | E23517390 |
| NIH Device Record Key | 0ba30bb9-8d86-4a9a-afc4-a592cf4c9e54 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | P&R Repair Kit |
| Version Model Number | 1739 |
| Catalog Number | 1739 |
| 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 | 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 |
| Phone | 760-566-3528 |
| ckaemmerlen@shofu.com |
| Handling Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E23517390 [Primary] |
| KLE | Agent, Tooth Bonding, Resin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-08-09 |
| Device Publish Date | 2016-09-24 |
| E2351000T0 - TRINIA | 2026-03-16 TRINIA DISC 98mm x 15mm Ivory |
| E2351000TP0 - TRINIA | 2026-03-16 TRINIA DISC 98mm x 15mm Pink |
| E2351001T0 - TRINIA | 2026-03-16 TRINIA DISC 98mm x 25mm Ivory |
| E2351001TP0 - TRINIA | 2026-03-16 TRINIA DISC 98mm x 25mm Pink |
| E2351002T0 - TRINIA | 2026-03-16 TRINIA BLOCK 55mm x 19mm x 15mm Ivory |
| E2351003T0 - TRINIA | 2026-03-16 TRINIA BLOCK 40mm x 19mm x 15mm Ivory |
| E2351004T0 - TRINIA | 2026-03-16 TRINIA D-SHAPE 89mm x 71mm x 15mm Ivory |
| E2351004TP0 - TRINIA | 2026-03-16 TRINIA D-SHAPE 89mm x 71mm x 15mm Pink |