I-SiL Jumbo Heavy Body

GUDID 08809262958034

Spident Co., Ltd.

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: 08809262958034
• NIH Device Record Key: 3d13f98e-4f23-4f2f-9c37-c9f34697397f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-SiL Jumbo Heavy Body
• Version Model Number: 102-0602
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00020080921224 [Package]; Package: [110 Units]; Discontinued: 2022-09-21; In Commercial Distribution
GS1	02018122616236 [Package]; Package: [500 Units]; Discontinued: 2019-12-31; In Commercial Distribution
GS1	02021023519025 [Package]; Package: [50 Units]; In Commercial Distribution
GS1	08809262958034 [Primary]

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-17
• Device Publish Date: 2017-02-20

Devices Manufactured by Spident Co., Ltd.

• 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