Prodent

GUDID 06970553800154

Prodent Dental Technology (Shenzhen) Co., Ltd.

Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture Partial denture

• Primary Device ID: 06970553800154
• NIH Device Record Key: f6a0da57-d165-4465-9bc8-245039adce89
• 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	06970553800154 [Primary]
GS1	10697055380015 [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