MD-Temp Plus(White20g)

GUDID 08806387893905

MD-Temp Plus is used for temporary filling material. It is supplied in a 20, 30 or 40g jar in either white (tooth-like) or pink (gum-like), and individually boxed. It is intended primarily as a temporary filling material for most cavities or damages but may be used by the dentist for other temporary restorations. MD-Temp plus is water-based temporary filling materials used for part of a tooth or multiple teeth. The curing reaction is the hydration reaction of the gypsum, and the semi-gypsum is cured as it is exposed to saliva or water in the oral cavity.

Meta Biomed Co., Ltd.

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• Primary Device ID: 08806387893905
• NIH Device Record Key: 4a086200-9b54-4b04-afac-8cc8a37dd2b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MD-Temp Plus(White20g)
• Version Model Number: 9390
• Company DUNS: 688322841
• Company Name: Meta Biomed 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	08806387893905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190724

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-22
• Device Publish Date: 2019-11-14

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