MiYO Esthetic System 0973

GUDID 00817340025811

JENSEN INDUSTRIES INC.

Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit Dental porcelain/ceramic restoration kit

• Primary Device ID: 00817340025811
• NIH Device Record Key: d4e0a28d-b277-4d12-9c89-bb594e25c726
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiYO Esthetic System
• Version Model Number: MiYO 850 Trans Shade C Fluor Paste 4g
• Catalog Number: 0973
• 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: false
• 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	00817340025811 [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: 2022-08-02
• Device Publish Date: 2022-07-25

On-Brand Devices [MiYO Esthetic System]

• 00817340025118: MiYO Enamel Effect Liquid Jensen XT
• 00817340025125: MiYO Enamel Effect Liquid Jensen XT 15ml
• 00817340025538: MiYO Gingival Thistle Paste 4g
• 00817340025521: MiYO Gingival Sable Paste 4g
• 00817340025514: MiYO Trans Lumin Plus Fluor paste 4g
• 00817340025507: MiYO Trans Slate Fluor paste 4g
• 00817340025491: MiYO Trans Cobalt Fluor paste 4g
• 00817340025484: MiYO Trans Sage Fluor paste 4g
• 00817340025446: MiYO Gingival Salmon Paste 4g
• 00817340025439: MiYO Gingival Trans Copper Paste 4g
• 00817340025422: MiYO Gingival Trans Raspberry Paste 4g
• 00817340025415: MiYO Gingival Sorbet Paste 4g
• 00817340025408: MiYO Gingival Merlot Paste 4g
• 00817340025392: MiYO Gingival Plum Paste 4g
• 00817340025385: MiYO Gingival Trans Midnight Paste 4g
• 00817340025378: MiYO Gingival Crimson Paste 4g
• 00817340025361: MiYO Gingival Flamingo Paste 4g
• 00817340025354: MiYO Trans Shade D Fluor paste 4g
• 00817340025347: MiYO Trans Shade C Fluor paste 4g
• 00817340025330: MiYO Trans Shade B Fluor paste 4g
• 00817340025323: MiYO Trans Shade A Fluor paste 4g
• 00817340025316: MiYO Trans Lumin Fluor paste 4g
• 00817340025309: MiYO Trans Smoke Fluor paste 4g
• 00817340025248: MiYO Mamelon Pumpkin Fluor paste 4g
• 00817340025231: MiYO Mamelon Coral Fluor paste 4g
• 00817340025224: MiYO Mamelon Wheat Fluor paste 4g
• 00817340025217: MiYO Halo Autumn Fluor paste 4g
• 00817340025200: MiYO Halo Spring Fluor paste 4g
• 00817340025194: MiYO Trans Clementine Fluor paste 4g
• 00817340025187: MiYO Trans Straw Fluor paste 4g
• 00817340025170: MiYO Trans Lotus Fluor paste 4g
• 00817340025163: MiYO Trans Storm Fluor paste 4g
• 00817340025149: MiYO Linen Fluor paste 4g
• 00817340025132: MiYO Snow Fluor paste 4g
• 00817340025477: MiYO Gingival Structure Frost paste 4g
• 00817340025460: MiYO Gingival Structure Rouge paste 4g
• 00817340025453: MiYO Gingival Structure Orchid paste 4g
• 00817340025286: MiYO Structure Enamel Flour paste 4g
• 00817340025255: MiYO Structure Window Flour paste 4g
• 00817340025156: MiYO Fissure Flour powder 4g
• 00817340025644: MiYO Esthetic System Chairside Kit
• 00817340025743: MiYO Gingival Venule Powder 4g
• 00817340025705: MiYO Structure Enamel High Fusing Paste 4g
• 00817340025699: MiYO Structure Window High Fusing Paste 4g
• 00817340025675: MiYO Gingival Carnation Paste 4g
• 00817340025668: MiYO Trans Sunflower Fluor Paste 4g
• 00817340025651: MiYO Gingival Glaze paste no Fluor 4g
• 00817340025750: MiYO Gingival Esthetic System Kit
• 00817340025682: MiYO Trans Garnet Paste 4g
• 00817340025774: MiYO Gingival Hibiscus Paste 4g