FDA.reportPublic FDA data

STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR

Primary DI
07630031702364
Brand
STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR
Company
Institut Straumann AG
Model
Bridges (implant borne)
Catalog number
010.1106
Device description
CARES® Basic Fixed Bar, 4 Implants, coron®/TAN
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K101465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101465000STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BARInstitut Straumann AG2010-12-13NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031702364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031702364076300317023647630031702364

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant prosthetic teeth barA small rod, usually cast or brazed, that bears prosthetic teeth and allows them to be attached to the dental implant abutments.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031782298Straumann Modular CassetteStorage Systems / Cassettes041.8192026-05-07
07630031770936Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53442026-04-08
07630031770943Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53452026-04-08
07630031770950Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53462026-04-08
07630031770967Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53552026-04-08
07630031770974Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53562026-04-08
07630031770981Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53572026-04-08
07630031770998Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53582026-04-08
07630031771001Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53592026-04-08
07630031771018Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53602026-04-08
07630031771025Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53612026-04-08
07630031771032Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53622026-04-08
07630031771049Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53632026-04-08
07630031771056Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53642026-04-08
07630031771063Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53652026-04-08
07630031771070Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53662026-04-08
07630031771087Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53672026-04-08
07630031771094Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53682026-04-08
07630031771100Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53692026-04-08
07630031771117Straumann Variobase Abutments XC for Bridge/BarFinal Abutments010.53702026-04-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
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