Zuga

GUDID 00853768007619

Titanium Abutment, 5.0mm, 7.0mm height x 4.5mm gum height

ZUGA MEDICAL, INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00853768007619
• NIH Device Record Key: 86e8de1a-8efa-4342-8164-bc37f4d81af3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zuga
• Version Model Number: TAA-500-470
• Company DUNS: 055605664
• Company Name: ZUGA MEDICAL, 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: 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

Customer Support Contacts

• Phone: 2162925910
• Email: sales@zugamedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853768007619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122664

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00853768007619]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-01-16

On-Brand Devices [Zuga]

• 00854382006996: Impression Transfer Open Long 5.0mm
• 00854382006972: Impression Transfer 5.00mm
• 00854382006965: Impression Transfer 4.30mm
• 00854382006958: Impression Transfer 3.50mm
• 00854382006934: Implant Drill Extender
• 00854382006927: Ratchet
• 00854382006910: Gum Punch
• 00854382006903: Gum Punch
• 00854382006897: Gum Punch
• 00854382006880: Twist Drill 5.00mm x 15mm
• 00854382006873: Twist Drill 5.00mm x 13mm
• 00854382006866: Twist Drill 5.00mm x 10mm
• 00854382006859: Twist Drill 5.00mm x 8mm
• 00854382006842: Twist Drill 4.30mm x 15mm
• 00854382006835: Twist Drill 4.30mm x 13mm
• 00854382006828: Twist Drill 4.30mm x 10mm
• 00854382006811: Twist Drill 4.30mm x 8mm
• 00854382006804: Impression Analog, 5.0mm
• 00854382006798: Impression Analog, 4.3mm
• 00854382006781: Impression Analog, 3.5mm
• 00854382006743: Placement Pin
• 00854382006729: Margin Ring, 5.0mm x 3.5mm
• 00854382006705: Margin Ring, 4.3mm x 3.6mm
• 00854382006682: Margin Ring, 3.5mm x 3.6mm
• 00854382006651: Tap Drill 5.00mm
• 00854382006644: Tap Drill 4.30mm
• 00854382006637: Tap Drill 3.50mm
• 00854382006620: Twist Drill 3.50mm x 8mm
• 00854382006613: Twist Drill 3.50mm x 10mm
• 00854382006606: Twist Drill 3.50mm x 13mm
• 00854382006590: Twist Drill 3.50mm x 15mm
• 00854382006583: Impression Transfer Open Long 4.30mm
• 00854382006576: Pilot Drill
• 00854382006545: Titanium Abutment, 5.0mm x 7.0mm
• 00854382006538: Titanium Abutment, 5.0mm x 5.5mm
• 00854382006521: Titanium Abutment, 5.0mm x 4.0mm
• 00854382006514: Titanium Abutment, 4.3mm x 7.0mm
• 00854382006507: Titanium Abutment, 4.3mm x 5.5mm
• 00854382006491: Titanium Abutment, 4.3mm x 4.0mm
• 00854382006484: Titanium Abutment, 3.5mm x 7.0mm
• 00854382006477: Titanium Abutment, 3.5mm x 5.5mm
• 00854382006460: Titanium Abutment, 3.5mm x 4.0mm
• 00854382006446: Impression Transfer Open Short 5.00mm
• 00854382006439: Guided Tool Kit
• 00854382006422: Parallel Pin, 5.0mm
• 00854382006415: Parallel Pin, 4.3mm
• 00854382006408: Parallel Pin, 3.5mm
• 00854382006392: Round Burr, 3.1mm
• 00854382006385: Round Burr, 2.3mm
• 00854382006378: Round Bur, 1.35mm