Contour Healer

GUDID 00859598007102

Temporary analog for Straumann Bone Level Compatible device

CONTOUR HEALER, LLC

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00859598007102
NIH Device Record Key757015a1-1a5c-4e09-b2bd-70091af6596b
Commercial Distribution StatusIn Commercial Distribution
Brand NameContour Healer
Version Model NumberStraumann Bone Level Compatible
Company DUNS032086267
Company NameCONTOUR HEALER, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone757-288-6671
Emailcontourhealer@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859598007102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00859598007102]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-12-07
Device Publish Date2018-09-07

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

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