JET SET-4 TOOTH SHADE 3893F

GUDID D6503893F0

VERY FAST CURING PROVISIONAL CROWN AND BRIDGE ACRYLIC RESIN POWDER AND LIQUID

LANG DENTAL MANUFACTURING CO., INC.

Temporary dental crown/bridge resin

• Primary Device ID: D6503893F0
• NIH Device Record Key: 05f561c8-ebed-49f1-860c-f04915c70681
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JET SET-4 TOOTH SHADE
• Version Model Number: 6/1 POWDER KIT WITH DISPENSER CAP
• Catalog Number: 3893F
• Company DUNS: 005185798
• Company Name: LANG DENTAL MANUFACTURING CO., INC.
• 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	D6503893F0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083195

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

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: 2021-10-29
• Device Publish Date: 2017-09-21

On-Brand Devices [JET SET-4 TOOTH SHADE]

• D6503893P0: VERY FAST CURING PROVISIONAL CROWN AND BRIDGE ACRYLIC RESIN POWDER AND LIQUID
• D6503893F0: VERY FAST CURING PROVISIONAL CROWN AND BRIDGE ACRYLIC RESIN POWDER AND LIQUID
• D6503893C0: VERY FAST CURING PROVISIONAL CROWN AND BRIDGE ACRYLIC RESIN POWDER AND LIQUID