I-SIL Putty Fast Set

GUDID 08809262959864

Vinyl Polysiloxane Impression Material

Spident Co., Ltd.

Silicone dental impression material

• Primary Device ID: 08809262959864
• NIH Device Record Key: 90c10a61-b0bc-4e83-a5a5-6c322fe8b8df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-SIL Putty Fast Set
• Version Model Number: 102-0502
• 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	00020070922224 [Package]; Package: [90 Units]; Discontinued: 2022-09-22; In Commercial Distribution
GS1	02021022819027 [Package]; Package: [216 Units]; In Commercial Distribution
GS1	08809262959864 [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: 4
• 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