Contour Healer

Basic Information

• Brand Name: Contour Healer
• Primary DI: 00859598007010
• Version / Model: Nobel ™ Replace Compatible 4.3 mm
• Company Name: CONTOUR HEALER, LLC
• Labeler DUNS: 032086267
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-07
• Public Version: 2
• Public Version Date: 2018-12-07
• Public Version Status: Update
• Public Device Record Key: 44096be3-9320-46b1-965b-a5bd4be3de2f

Device Description

Temporary analog for Nobel ™ Replace Compatible 4.3 mm Compatible device

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHA	Abutment, Implant, Dental, Endosseous	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44880	Dental implant suprastructure, temporary, preformed, single-use	A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859598007010	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K112099	000