SCREW

GUDID 07290113355392

One Piece Protective Cap

DENTIN IMPLANTS TECHNOLOGIES LTD

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07290113355392
• NIH Device Record Key: 2c19fdb6-a364-436b-bb57-2fe4b451e76f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCREW
• Version Model Number: DOP-PR00
• Company DUNS: 600215680
• Company Name: DENTIN IMPLANTS TECHNOLOGIES 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: false
• 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	07290113355392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120530

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

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: 2018-12-07
• Device Publish Date: 2018-09-10

On-Brand Devices [SCREW]

• 07290113355392: One Piece Protective Cap
• 07290113351905: Cover Screw