FDA.reportPublic FDA data

Contour Healer

Primary DI
00859598007102
Brand
Contour Healer
Company
CONTOUR HEALER, LLC
Model
Straumann Bone Level Compatible
Device description
Temporary analog for Straumann Bone Level Compatible device
Published
2018-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112099000CONTOUR HEALERContour Healer, LLC2012-02-03NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859598007102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859598007102008595980071028595980071020859598007102

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
757-288-6671contourhealer@gmail.com

Regulatory Flags#

DUNS number
032086267
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859598007140Contour HealerStraumann Bone Level Compatible NC90117A2020-09-08
00859598007157Contour HealerStraumann RC Premolar90118A2020-09-08
90859598007136Contour HealerStraumann Bone Level Compatible RC90108B2020-09-08
00859598007003Contour HealerNobel ™ Replace Compatible 3.5 mm2018-09-07
00859598007010Contour HealerNobel ™ Replace Compatible 4.3 mm2018-09-07
00859598007027Contour HealerNobel ™ Replace Compatible 5.0 mm2018-09-07
00859598007034Contour HealerNobel ™ Conical Connection Compatible 3.5 mm2018-09-07
00859598007041Contour HealerNobel ™ Conical Connection Compatible 4.3/5.0 mm2018-09-07
00859598007058Contour HealerZimmer ™ /BioHorizons ™ Compatible 3.5 mm2018-09-07
00859598007065Contour HealerZimmer ™ /BioHorizons ™ Compatible 4.5 mm2018-09-07
00859598007072Contour HealerZimmer ™ /BioHorizons ™ Compatible 5.7 mm2018-09-07
00859598007089Contour HealerBiomet 3i ™ Compatible 4.0 mm2018-09-07
00859598007096Contour HealerBiomet 3i ™ Compatible 5.0 mm2018-09-07
00859598007119Contour HealerHiossen Standard Connection Compatible2018-09-07
00859598007126Contour HealerNobel ™ Replace Compatible 3.5 mm2018-09-07

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