GlasSpan Flexible Ceramic Bonding Material Standard Kit 701770

GUDID 00723896011737

Contains (3) GlasSpan Flexible Ceramic Bonding Rope Small (3) GlasSpan Flexible Ceramic Bonding Rope Medium (3)GlasSpan Flexible Ceramic Bonding Rope large and (3) GlasSpan Flexible Ceramic Bonding Tape

PRACTICON, INC.

Dental reinforcing fibre

• Primary Device ID: 00723896011737
• NIH Device Record Key: de91a939-5c89-42fb-9a47-e3b7569ac9a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GlasSpan Flexible Ceramic Bonding Material Standard Kit
• Version Model Number: STANDARD KIT
• Catalog Number: 701770
• Company DUNS: 119193803
• Company Name: PRACTICON, 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: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00723896011737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922673

FDA Product Code

• ELS: Splint, Endodontic Stabilizing

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: 2019-02-07
• Device Publish Date: 2019-01-07

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