FDA.reportPublic FDA data

Contour Healer

Primary DI
00859598007072
Brand
Contour Healer
Company
CONTOUR HEALER, LLC
Model
Zimmer ™ /BioHorizons ™ Compatible 5.7 mm
Device description
Temporary analog for Zimmer ™ /BioHorizons ™ Compatible 5.7 mm device
Published
2018-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00859598007072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859598007072008595980070728595980070720859598007072

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
00859598007089Contour HealerBiomet 3i ™ Compatible 4.0 mm2018-09-07
00859598007096Contour HealerBiomet 3i ™ Compatible 5.0 mm2018-09-07
00859598007102Contour HealerStraumann Bone Level Compatible2018-09-07
00859598007119Contour HealerHiossen Standard Connection Compatible2018-09-07
00859598007126Contour HealerNobel ™ Replace Compatible 3.5 mm2018-09-07

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Primary DI, Brand, Company table
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