ZMD-1000B TEMPORARY

GUDID 08806169157126

Dental Temporary Resin / ZMD-1000B TEMPORARY

DENTIS CO., LTD.

Dental crown/bridge resin, temporary

• Primary Device ID: 08806169157126
• NIH Device Record Key: 427ba89e-088a-40b9-8035-bfed0f0106f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZMD-1000B TEMPORARY
• Version Model Number: ZMD-1000B TEMPORARY
• Company DUNS: 688204158
• Company Name: DENTIS 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: 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	08806169157126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180657

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: 2019-06-04
• Device Publish Date: 2019-05-27

Devices Manufactured by DENTIS CO., LTD.

• 08800053035163 - s-Clean SQ-SL Fixture: 2021-03-10 Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
• 08800053022385 - s-Clean SQ-SL Fixture: 2021-03-08 Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
• 08806169155979 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1 X L7.0 mm
• 08806169155986 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L7.5mm
• 08806169155993 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L9.5mm
• 08806169156006 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L11.5mm
• 08806169156013 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L13.5mm
• 08806169156020 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.4mm X L7.0mm