FDA.reportPublic FDA data

P.004 ABUTMENTS, TEMPORARY COPINGS, PROTECTIVE CAPS, PERMANENT COPINGS

Primary DI
07630031709516
Brand
P.004 ABUTMENTS, TEMPORARY COPINGS, PROTECTIVE CAPS, PERMANENT COPINGS
Company
Institut Straumann AG
Model
1
Catalog number
023.2744
Device description
NC Coping, for bridge on Multi-Base Abutment, straight, D 4.5mm, POM
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
K080239000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080239000P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGSStraumann Manufacturing, Inc.2008-04-30NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031709516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031709516076300317095167630031709516

GMDN Terms#

Term, Definition table
TermDefinition
Dental casting waxA waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the "lost-wax" casting technique. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter4.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
483599259
Device count
1
Lot or batch
true
Expiration date on label
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

Other Devices Sharing Product Codes#

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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