FDA.reportPublic FDA data

Contour Healer

Primary DI
00859598007157
Brand
Contour Healer
Company
CONTOUR HEALER, LLC
Model
Straumann RC Premolar
Catalog number
90118A
Published
2020-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00859598007157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859598007157008595980071578595980071570859598007157

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
Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
7574283921contourhealer@gmail.com

Regulatory Flags#

DUNS number
032086267
Device count
1
DM exempt
true
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
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
00859598007102Contour HealerStraumann Bone Level Compatible2018-09-07
00859598007119Contour HealerHiossen Standard Connection Compatible2018-09-07
00859598007126Contour HealerNobel ™ Replace Compatible 3.5 mm2018-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNHA2026-07-13
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
05712821017123Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017130Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017147Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017154Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017161Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017178Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017185Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017192Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017208Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017215Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017222Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017239Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017246Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017253Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017260Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017277Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017284Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017291Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017307Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017314Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017321Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017338Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017345Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
05712821017352Elos Accurate DigiLoc AbutmentElos Medtech Pinol A/SNHA2026-06-26
D99025HMINIOA0Omnibut, Hiossen Mini, 2.5GHSMART DENTURE CONVERSIONS, LLCNHA2026-06-26
D99025HMINIOA140Omnibut, Hiossen Mini, 2.5GH, M1.4SMART DENTURE CONVERSIONS, LLCNHA2026-06-26