Synthetic Polymer Teeth 1*28*4

GUDID 06970402676599

SHANDONG HUGE DENTAL MATERIAL CORPORATION

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• Primary Device ID: 06970402676599
• NIH Device Record Key: dc1175bc-092a-41b7-bfe8-72db3eb3ef07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synthetic Polymer Teeth
• Version Model Number: KAILI
• Catalog Number: 1*28*4
• Company DUNS: 528184691
• Company Name: SHANDONG HUGE DENTAL MATERIAL CORPORATION
• 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
GS1	06970402676599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101029

FDA Product Code

• ELM: Denture, Plastic, Teeth

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: 2021-11-01
• Device Publish Date: 2021-10-22

On-Brand Devices [Synthetic Polymer Teeth]

• 06970402677046: Living Mould Guide
• 06970402677039: Acrylic Teeth Shade Guide-Two layers
• 06970402677022: Acrylic Teeth Shade Guide-Two layers
• 06970402677015: Acrylic Teeth Shade Guide-Two layers
• 06970402677008: Acrylic Teeth Shade Guide-MAIST
• 06970402676995: Acrylic Teeth Shade Guide-MAIST
• 06970402676988: Acrylic Shell
• 06970402676971: Acrylic Shell
• 06970402676964: Acrylic Shell
• 06970402676957: SENIORS
• 06970402676940: KAIPLUS
• 06970402676933: KAIPLUS
• 06970402676926: KAIPLUS
• 06970402676919: KAIPLUS
• 06970402676902: BLUEBELL
• 06970402676896: BLUEBELL
• 06970402676889: BLUEBELL
• 06970402676872: BLUEBELL
• 06970402676865: IMPLA
• 06970402676858: IMPLA
• 06970402676841: IMPLA
• 06970402676834: IMPLA
• 06970402676827: IMPLA
• 06970402676810: KAITONG
• 06970402676803: KAITONG
• 06970402676797: KAITONG
• 06970402676780: KAITONG
• 06970402676773: KAIJING
• 06970402676766: KAIJING
• 06970402676759: KAIJING
• 06970402676742: KAIJING
• 06970402676735: SONNING
• 06970402676728: SONNING
• 06970402676711: SONNING
• 06970402676704: SONNING
• 06970402676698: KAIFENG
• 06970402676681: KAIFENG
• 06970402676674: KAIFENG
• 06970402676667: KAIFENG
• 06970402676650: MAIST
• 06970402676643: MAIST
• 06970402676636: MAIST
• 06970402676629: MAIST
• 06970402676612: KAILI
• 06970402676605: KAILI
• 06970402676599: KAILI
• 06970402676582: KAILI