JET SET-4 TOOTH SHADW POWDER 382066M

GUDID D650382066M0

VERY FAST CURING PROVISIONAL CROWN & BRIDE ACRYLIC RESIN POWDER

LANG DENTAL MANUFACTURING CO., INC.

Temporary dental crown/bridge resin

• Primary Device ID: D650382066M0
• NIH Device Record Key: 5bf88585-e9de-452f-957e-250c8fad6d35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JET SET-4 TOOTH SHADW POWDER
• Version Model Number: 100 GRAM SHADE 66/A3
• Catalog Number: 382066M
• 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	D650382066M0 [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: 2016-09-01

Devices Manufactured by LANG DENTAL MANUFACTURING CO., INC.

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