truTent 454391002

GUDID 00614950008568

truTent Tenting Screw 5mm Head, 1.5mm Thread, 12 MM Total Length

ACE SURGICAL SUPPLY CO., INC.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00614950008568
• NIH Device Record Key: b3a05ca8-4167-4a12-8430-22c95d26b737
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: truTent
• Version Model Number: 454391002
• Catalog Number: 454391002
• Company DUNS: 042763706
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: +1(508)588-3100
• Email: ritaknight@acesurgical.com
• Phone: +1(508)588-3100
• Email: ritaknight@acesurgical.com

Device Dimensions

• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614950008568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954513

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-12-01

On-Brand Devices [truTent]

• 00614950008575: truTent Tenting Screw 5mm Head, 1.5mm Thread, 14 MM Total Length
• 00614950008568: truTent Tenting Screw 5mm Head, 1.5mm Thread, 12 MM Total Length
• 00614950008551: truTent Tenting Screw 5mm Head, 1.5mm Thread, 10 MM Total Length