Silginat 13848

GUDID E217138481

Silginat Superbulk

Kettenbach GmbH & Co. KG

Silicone dental impression material

• Primary Device ID: E217138481
• NIH Device Record Key: 82a46e2b-8de0-4c98-8ca0-149859f4b8b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silginat
• Version Model Number: 13848
• Catalog Number: 13848
• 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	E217138481 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

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