Customized Abutment and Screw

GUDID 06932195385331

Pre-milled Blank

Chengdu Besmile Medical Technology Co., Ltd.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 06932195385331
• NIH Device Record Key: 32b60eec-8bde-448f-b5f2-73555c7b1419
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Customized Abutment and Screw
• Version Model Number: HE-05
• Company DUNS: 554494754
• Company Name: Chengdu Besmile Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06932195385331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242768

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

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: 2025-09-30
• Device Publish Date: 2025-09-22

On-Brand Devices [Customized Abutment and Screw]

• 06932195385331: Pre-milled Blank
• 06932195385324: Pre-milled Blank
• 06932195385317: Pre-milled Blank
• 06932195385300: Pre-milled Blank
• 06932195385294: HE-05
• 06932195385287: HE-04
• 06932195385270: QU-03
• 06932195385263: QU-02