| Primary Device ID | E2352171B1 |
| NIH Device Record Key | 900df90e-b156-4846-9ff8-eac8f15d3c1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DentaLaze Kit |
| Version Model Number | DL001 |
| Catalog Number | DL001 |
| Company DUNS | 054618202 |
| Company Name | SHOFU DENTAL CORPORATION |
| Device Count | 10 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E2352171B1 [Unit of Use] |
| HIBCC | E235DL0010 [Primary] |
| NVK | Laser, Dental, Soft Tissue |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
[E2352171B1]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-14 |
| Device Publish Date | 2023-06-06 |
| E235D18B1MN0 - DENTADISC | 2026-02-10 DentaDisc CAD/CAM PMMA Disc 98.5x18mm B1.MN |
| E235D20A1MN0 - DENTADISC | 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X20mm A1. MN |
| E235D20B1MN0 - DENTADISC | 2026-02-10 DentaDisc CAD/CAM PMMA DISC 98.5x20mm B1.MN |
| E235D25A1MN0 - DENTADISC | 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X25mm A1. MN |
| E235D25A2MN0 - DENTADISC | 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5x25mm A2. MN |
| E235D30A1MN0 - DENTADISC | 2026-02-10 DentaDisc CAD/CAM PMMA DISC.98.5x30mm A1. MN |
| E235D30A2MN0 - DENTADISC | 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X30mm A2. MN |
| E235D30B1MN0 - DENTADISC | 2026-02-10 DentaDisc CAD/CAM PMMA DISC. 98.5X30mm B1. MN |