XTCERA

GUDID 06970544020090

ST

Shenzhen Xiangtong Photoelectricity Technology Co., Ltd

Dental porcelain/ceramic restoration kit

• Primary Device ID: 06970544020090
• NIH Device Record Key: 62dd4545-8227-4eb9-a104-2828b2ca6df2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XTCERA
• Version Model Number: XW98*10
• Company DUNS: 547044326
• Company Name: Shenzhen Xiangtong Photoelectricity Technology 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: false
• Expiration Date: true
• 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	06970544020090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153767

FDA Product Code

• EIH: Powder, Porcelain

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: 2016-09-24

On-Brand Devices [XTCERA]

• 06970544020243: SHT
• 06970544020236: SHT
• 06970544020229: SHT
• 06970544020212: SHT
• 06970544020205: SHT
• 06970544020199: SHT
• 06970544020182: SHT
• 06970544020175: SHT
• 06970544020168: ST
• 06970544020151: ST
• 06970544020144: ST
• 06970544020137: ST
• 06970544020120: ST
• 06970544020113: ST
• 06970544020106: ST
• 06970544020090: ST
• 06970544020083: HT
• 06970544020076: HT
• 06970544020069: HT
• 06970544020052: HT
• 06970544020045: HT
• 06970544020038: HT
• 06970544020021: HT
• 06970544020014: HT