Silginat 1382611

GUDID E21713826111

Silginat Strawberry Normal pack

Kettenbach GmbH & Co. KG

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: E21713826111
• NIH Device Record Key: 3ee57532-ecf1-4f73-8356-f51291db101f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silginat
• Version Model Number: 1382611
• Catalog Number: 1382611
• Company DUNS: 316803246
• Company Name: Kettenbach GmbH & Co. KG
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E21713826111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082157

FDA Product Code

• ELW: Material, Impression

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-28
• Device Publish Date: 2020-12-18

On-Brand Devices [Silginat ]

• E217147151: Silginat Strawberry Refill pack
• E217147141: Silginat Strawberry Intro pack
• E217147131: Silginat Refill pack
• E217147121: Silginat Intro pack
• E217138481: Silginat Superbulk
• E217138471: Silginat Bulk pack
• E217138461: Silginat Normal pack
• E217138271: Silginat Strawberry Bulk pack
• E217138261: Silginat Strawberry Normal pack
• E21713847111: Silginat Bulk pack
• E21713846111: Silginat Normal pack
• E21713827111: Silginat Strawberry Bulk pack
• E21713826111: Silginat Strawberry Normal pack