SCOTT'S SELECT TEMPORARY C&B STD PKG B1 193-1257

GUDID D77819312570

SCOTT'S DENTAL SUPPLY L.L.C.

Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Dental crown/bridge resin, temporary Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin Temporary dental crown/bridge resin

• Primary Device ID: D77819312570
• NIH Device Record Key: dcf51320-9fe0-4fc5-813a-3f61298f4fac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCOTT'S SELECT TEMPORARY C&B STD PKG B1
• Version Model Number: 193-1257
• Catalog Number: 193-1257
• Company DUNS: 137217043
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• 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: 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
HIBCC	D77819312570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960122

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-13