| Primary Device ID | 08809262959888 |
| NIH Device Record Key | 38f899ad-a5bf-40be-8f45-a8e2ce00325c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | I-SIL Bite Registration Fast Set |
| Version Model Number | 102-0101 |
| Company DUNS | 689370711 |
| Company Name | Spident Co., Ltd. |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 02021023019020 [Package] Package: [500 Units] In Commercial Distribution |
| GS1 | 08809262959888 [Primary] |
| ELW | Material, Impression |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-05-17 |
| Device Publish Date | 2017-02-20 |
| 08809262954173 - Tempro Blue | 2021-01-26 Light cured, single component, provisional filling material for temporary restorations. |
| 08809262954524 - Base It | 2021-01-26 Light-cured base/liner containing calcium hydroxyapatite in urethane methacrylate oligomer. |
| 20200623170027 - EsFlow LV A2 Syringe | 2021-01-26 |
| 20200723170026 - EsFlow LV A3 Syringe | 2021-01-26 |
| 00210205180012 - EsCom100 A4 Syringe | 2021-01-26 Nano-hybrid universal composite resin for posterior and anterior restorations. |
| 20210205180023 - EsCom 100 B1 Syringe | 2021-01-26 |
| 08809262955576 - EsCom 100 A1 Capsules | 2021-01-26 |
| 20200523170066 - EsCom 100 A3.5 Capsules | 2021-01-26 |