Gold Cylinder

GUDID 08806169105530

Ø5.5, L:3.5mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169105530
• NIH Device Record Key: b57ec10b-5e6b-47fa-a16f-2c31dc31a983
• Commercial Distribution Discontinuation: 2019-05-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Gold Cylinder
• Version Model Number: DEWGCH
• 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: false
• 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	08806169105530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082843

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

[08806169105530]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-08-07

On-Brand Devices [Gold Cylinder]

• 08806169105530: Ø5.5, L:3.5mm
• 08806169105523: Ø5.5, L:3.5mm
• 08806169105516: Ø4.8, L:3.5mm
• 08806169105509: Ø4.8, L:3.5mm
• 08806169105493: Ø4.8, L:5.7mm
• 08806169105486: Ø4.8, L:5.7mm
• 08806169110343: Ø6.0x14.8mm
• 08806169110336: Ø6.0x14.8mm
• 08806169110329: Ø5.5x14.8mm
• 08806169110305: Ø4.8x14.8mm
• 08806169110299: Ø4.8x14.8mm
• 08806169110282: Ø4.5x14.8mm
• 08806169110275: Ø4.5x14.8mm
• 08806169110312: Ø5.5x14.8mm