Bloomden

GUDID 16974564883670

Bloomden Bioceramics (Hunan) Co., Ltd.

Dental appliance fabrication material, ceramic

• Primary Device ID: 16974564883670
• NIH Device Record Key: c2905983-1313-46bf-90ca-e5ecd28fb9fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bloomden
• Version Model Number: 95×16 ST-C-A4
• Company DUNS: 712529058
• Company Name: Bloomden Bioceramics (Hunan) Co., Ltd.
• 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: 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	16974564883670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212765

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: 2024-10-30
• Device Publish Date: 2024-10-22

On-Brand Devices [Bloomden]

• 06974564881563: 95×10 ST
• 06974564881556: 92×75×25 HT-plus
• 06974564881549: 92×75×20 HT-plus
• 06974564881532: 92×75×18 HT-plus
• 06974564881525: 92×75×12 HT-plus
• 06974564881518: 95×25 HT-plus
• 06974564881501: 95×22 HT-plus
• 06974564881495: 95×20 HT-plus
• 06974564881488: 95×18 HT-plus
• 06974564881471: 95×16 HT-plus
• 06974564881464: 95×14 HT-plus
• 06974564881457: 95×12 HT-plus
• 06974564881440: 95×10 HT-plus
• 06974564880948: 98×22 HT-plus
• 06974564880931: 98×20 HT-plus
• 06974564880924: 98×18 HT-plus
• 06974564880917: 98×14 HT-plus
• 06974564880900: 98×12 HT-plus
• 06974564880887: 98×16 HT-plus
• 06974564880641: 95×12 ST
• 06974564880573: 98×25 HT-plus
• 06974564880245: 95×14 ST
• 06974564880238: 92×75×16 HT-plus
• 06974564880221: 92×75×14 HT-plus
• 06974564880009: 98×10 HT-plus
• 06942075423374: 98×30 HT-plus
• 06942075421738: 92×75×22 HT-plus
• 06974564881655: 92×75×25 ST
• 06974564881648: 92×75×20 ST
• 06974564881631: 92×75×18 ST
• 06974564881624: 92×75×16 ST
• 06974564881617: 92×75×14 ST
• 06974564881600: 92×75×12 ST
• 06974564881594: 98×22 ST
• 06974564881587: 98×10 ST
• 06974564881570: 95×22 ST
• 06974564880672: 95×25 ST
• 06974564880665: 95×20 ST
• 06974564880658: 95×18 ST
• 06974564880627: 98×12 ST
• 06974564880610: 98×25 ST
• 06974564880603: 98×20 ST
• 06974564880597: 98×16 ST
• 06974564880580: 98×14 ST
• 06974564880252: 95×16 ST
• 06974564880092: 98×18 ST
• 06942075423367: 98×30 ST
• 06942075421745: 92×75×22 ST
• 06974564882256: 98×16 ST-C-BL4
• 06974564882249: 98×16 ST-C-BL3