Prodent

GUDID 06970553800161

Prodent Dental Technology (Shenzhen) Co., Ltd.

Partial denture

• Primary Device ID: 06970553800161
• NIH Device Record Key: dc55ec75-a8f1-491f-bd92-a18469cb2343
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prodent
• Version Model Number: N/A
• Company DUNS: 421194088
• Company Name: Prodent Dental Technology (Shenzhen) Co., Ltd.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• 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	06970553800161 [Primary]
GS1	10697055380016 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020253

FDA Product Code

• ELM: Denture, Plastic, Teeth

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-06

On-Brand Devices [Prodent]

• 06970553800215: N/A
• 06970553800208: N/A
• 06970553800192: N/A
• 06970553800185: N/A
• 06970553800178: N/A
• 06970553800161: N/A
• 06970553800154: N/A
• 06970553800147: N/A
• 06970553800130: N/A
• 06970553800123: 138972
• 06970553800116: N/A
• 06970553800109: N/A
• 06970553800102: N/A
• 06970553800096: N/A
• 06970553800093: N/A
• 06970553800089: N/A
• 06970553800086: N/A
• 06970553800079: N/A
• 06970553800072: N/A
• 06970553800065: 20/40412C
• 06970553800062: N/A
• 06970553800058: 160127
• 06970553800055: N/A
• 06970553800041: 1602203B
• 06970553800034: 20/40412B
• 06970553800031: 160127
• 06970553800027: V12707
• 06970553800024: 20/40412B
• 06970553800017: 20/40412B
• 06970553800010: 16012902C
• 06970553800003: 138972