Panasil 13405

GUDID E217134051

Panasil initial contact X-Light, Superbulk

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: E217134051
• NIH Device Record Key: aa5cd6ea-6594-46c6-810a-e76a6847e375
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panasil
• Version Model Number: 13405
• Catalog Number: 13405
• 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	E217134051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083701

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 [Panasil]

• E217S135601: Panasil tray Soft Heavy Fast Test pack
• E217S134001: Panasil initial contact X-Light Test Pack
• E217283101: Panasil initial contact Light Bonus pack
• E217283001: Panasil initial contact X-Light Bonus pack
• E217281451: Panasil contact two in one Light Promotion pack
• E217281441: Panasil contact plus X-Light Promotion pack
• E217281271: Panasil Putty Fast Set Promotion pack
• E217281261: Panasil Putty Soft Promotion pack
• E217147091: Panasil monophase Medium Refill pack
• E217147081: Panasil monophase Medium Intro pack
• E217147071: Panasil tray Soft Heavy Refill pack
• E217147061: Panasil tray Soft Heavy Intro pack
• E217147051: Panasil tray Fast Heavy Intro pack
• E217147041: Panasil tray Fast Heavy Intro pack
• E217147031: Panasil binetics Putty Soft Refill pack
• E217147021: Panasil binetics Putty Soft Intro pack
• E217147011: Panasil binetics Putty Fast Refill pack
• E217147001: Panasil binetics Putty Fast Intro pack
• E217135651: Panasil tray Soft Heavy Fast Superbulk
• E217135631: Panasil tray Soft Heavy Fast Bulk pack
• E217135611: Panasil tray Soft Heavy Fast Normal pack
• E217135551: Panasil tray Fast Heavy Superbulk
• E217135531: Panasil tray Fast Heavy Bulk pack
• E217135511: Panasil tray Fast Heavy Normal pack
• E217135451: Panasil tray Soft Heavy Superbulk
• E217135431: Panasil tray Soft Heavy Bulk pack
• E217135411: Panasil tray Soft Heavy Normal pack
• E217135011: Panasil monophase Medium Normal pack
• E217134911: Panasil initial contact Ultra-Light Fast Normal pack
• E217134901: Panasil initial contact Ultra-Light Normal pack
• E217134811: Panasil initial contact Regular Fast Normal pack
• E217134731: Panasil initial contact Light Fast Bulk pack
• E217134711: Panasil initial contact Light Fast Normal pack
• E217134631: Panasil initial contact X-Light Fast Bulk pack
• E217134611: Panasil initial contact X-Light Fast Normal pack
• E217134311: Panasil initial contact Regular Normal pack
• E217134301: Panasil initial contact Regular Sample
• E217134151: Panasil initial contact Light Superbulk
• E217134121: Panasil initial contact Light Bulk pack
• E217134111: Panasil initial contact Light Normal pack
• E217134101: Panasil initial contact Light Intro pack
• E217134021: Panasil initial contact X-Light Bulk pack
• E217134011: Panasil initial contact X-Light Normal pack
• E217134001: Panasil initial contact X-Light Intro pack
• E217118921: Panasil contact plus X-Light Normal pack
• E217117811: Panasil contact two in one Light Normal pack
• E217111431: Panasil Putty Fast Set Economy pack
• E217111411: Panasil Putty Fast Set Normal pack
• E217111401: Panasil Putty Fast Set Intro pack
• E217111231: Panasil Putty Soft Economy pack