InSync Ceramic System MI994

GUDID 00817340023381

JENSEN INDUSTRIES INC.

Dental porcelain/ceramic restoration kit

• Primary Device ID: 00817340023381
• NIH Device Record Key: 9e28725f-5318-4db6-8e1d-ee7d80d5daa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InSync Ceramic System
• Version Model Number: MiYO Gingival Esthetic System Kit
• Catalog Number: MI994
• Company DUNS: 060018587
• Company Name: JENSEN INDUSTRIES 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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
GS1	00817340023381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111743

FDA Product Code

• EIH: Powder, Porcelain

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: 2019-03-11
• Device Publish Date: 2019-02-07

On-Brand Devices [InSync Ceramic System]

• 00817340023367: InSync Universal Spray Glaze
• 00817340023329: MiYO Pink Gingival Finishing System Kit
• 00817340023312: MiYO Finishing System Kit
• 00817340023121: MiYo Finishing System Kit
• 00817340023114: InSync Peter Pizzi Layering Kit
• 00817340022216: InSync Advanced Layering Kit
• 00817340022209: InSync Basic Layering Kit
• 00817340022193: InSync FC Stain & Glaze Kit
• 00817340023381: MiYO Gingival Esthetic System Kit
• 00817340023374: MiYO Esthetic System Kit
• 00817340025545: InSync Glaze Paste Flour 4g
• 00817340025781: InSync Glaze / Stain Liquid 25ml