EXACTA Temp Xtra NA1-FS

GUDID 00815619021809

EXACTA DENTAL PRODUCTS INC

Dental crown/bridge resin, temporary

• Primary Device ID: 00815619021809
• NIH Device Record Key: 0fc38e72-5165-4106-b2fe-43d78bc1c933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXACTA Temp Xtra
• Version Model Number: Shade A1
• Catalog Number: NA1-FS
• Company DUNS: 016325552
• Company Name: EXACTA DENTAL PRODUCTS INC
• 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: true
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815619021809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102917

FDA Product Code

• EBG: Crown And Bridge, Temporary, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-30

On-Brand Devices [EXACTA Temp Xtra]

• 00815619021861: Shade C2
• 00815619021854: Shade Bleach
• 00815619021847: Shade B1
• 00815619021830: Shade A3.5
• 00815619021823: Shade A3
• 00815619021816: Shade A2
• 00815619021809: Shade A1
• 00815619020703: Shade C2
• 00815619020697: Shade BL
• 00815619020680: Shade B1
• 00815619020673: Shade A3.5
• 00815619020666: Shade A3
• 00815619020659: Shade A2
• 00815619020642: Shade A1