Contour Healer

GUDID 00859598007058

Temporary analog for Zimmer ™ /BioHorizons ™ Compatible 3.5 mm device

CONTOUR HEALER, LLC

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00859598007058
• NIH Device Record Key: 9c3af68a-41c3-47dd-be9e-d371ea6f3526
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contour Healer
• Version Model Number: Zimmer ™ /BioHorizons ™ Compatible 3.5 mm
• Company DUNS: 032086267
• Company Name: CONTOUR HEALER, LLC
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 757-288-6671
• Email: contourhealer@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859598007058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112099

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00859598007058]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-12-07
• Device Publish Date: 2018-09-07

On-Brand Devices [Contour Healer]

• 00859598007126: Temporary analog for Nobel Replace 3.5mm
• 00859598007119: Temporary analog for Hiossen Standard Connection Compatible device
• 00859598007102: Temporary analog for Straumann Bone Level Compatible device
• 00859598007096: Temporary analog for Biomet 3i ™ Compatible 5.0 mm device
• 00859598007089: Temporary analog for Biomet 3i ™ Compatible 4.0 mm device
• 00859598007072: Temporary analog for Zimmer ™ /BioHorizons ™ Compatible 5.7 mm device
• 00859598007065: Temporary analog for Zimmer ™ /BioHorizons ™ Compatible 4.5 mm device
• 00859598007058: Temporary analog for Zimmer ™ /BioHorizons ™ Compatible 3.5 mm device
• 00859598007041: Temporary analog for Nobel ™ Conical Connection Compatible 4.3/5.0 mm devices
• 00859598007034: Temporary analog for Nobel ™ Conical Connection Compatible 3.5 mm device
• 00859598007027: Temporary analog for Nobel ™ Replace Compatible 5.0 mm Compatible device
• 00859598007010: Temporary analog for Nobel ™ Replace Compatible 4.3 mm Compatible device
• 00859598007003: Temporary analog for Nobel ™ Replace Compatible 3.5 mm Compatible device
• 90859598007136: Straumann Bone Level Compatible RC
• 00859598007157: Straumann RC Premolar
• 00859598007140: Straumann Bone Level Compatible NC