FDA.reportPublic FDA data

Straumann Ceramic Healing Abutments

Primary DI
07630031745958
Brand
Straumann Ceramic Healing Abutments
Company
Institut Straumann AG
Model
Healing Components
Catalog number
024.4226Z
Device description
RC Healing Abutment, conical, Ø 5mm, H 6mm, ZrO2/TAN
Published
2022-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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
K192893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192893000Straumann Ceramic Healing AbutmentsInstitut Straumann AG2020-01-03NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031745958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031745958076300317459587630031745958

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height6Millimeter
Outer Diameter5Millimeter

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(801)448-8168info.usa@straumann.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031736451Straumann BoneceramicBoneCeramic070.1982022-04-01
07630031736468Straumann BoneceramicBoneCeramic070.1992022-04-01
07630031736475Straumann BoneceramicBoneCeramic070.2002022-04-01
07630031700155STRAUMANN GRANULESBoneCeramic070.2032015-09-24
07630031700162STRAUMANN GRANULESBoneCeramic070.2042015-09-24
07630031700179STRAUMANN GRANULESBoneCeramic070.2052015-09-24
07630031739575NAAnatomic drill guides010.40212022-11-10
07630031755537CoDiagnostiXAnatomic drill guides010.40302022-04-29
07630031739933Surgical Guide - 3D Printed Model2017010.40212018-07-19
07630031764263Straumann® BLC Implants - Indication WideningSLA Roxolid BL035.8218S2023-11-04
07630031764331Straumann® BLC Implants - Indication WideningSLActive Roxolid BL035.9218S2023-11-04
07630031778086NAsurgically Invasive Instruments066.50632026-06-03
07630031778093NAsurgically Invasive Instruments066.50642026-06-03
07630031778109NAsurgically Invasive Instruments066.50652026-06-03
07630031778116NAsurgically Invasive Instruments066.50662026-06-03
07630031778123NAsurgically Invasive Instruments066.50672026-06-03
07630031778130NAsurgically Invasive Instruments066.50682026-06-03
07630031778147NAsurgically Invasive Instruments066.50692026-06-03
07630031778154NAsurgically Invasive Instruments066.50702026-06-03
07630031778161NAsurgically Invasive Instruments066.50712026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968494138plant Implant System8dent Inc.NHA2026-10-15
088000968498028plant Implant System8dent Inc.NHA2026-10-15
088000968501748plant Implant System8dent Inc.NHA2026-10-15
088000968515228plant Implant System8dent Inc.NHA2026-10-15
088000968515398plant Implant System8dent Inc.NHA2026-10-15
088000968515538plant Implant System8dent Inc.NHA2026-10-15
088000968516078plant Implant System8dent Inc.NHA2026-10-15
088000968516148plant Implant System8dent Inc.NHA2026-10-15
088000968516218plant Implant System8dent Inc.NHA2026-10-15
088000968516388plant Implant System8dent Inc.NHA2026-10-15
088000968588358plant Implant System8dent Inc.NHA2026-10-15
088000968600678plant Implant System8dent Inc.NHA2026-10-15
088000968603028plant Implant System8dent Inc.NHA2026-10-15
088000968609068plant Implant System8dent Inc.NHA2026-10-15
088000968616758plant Implant System8dent Inc.NHA2026-10-15
088000968620618plant Implant System8dent Inc.NHA2026-10-15
088000968621848plant Implant System8dent Inc.NHA2026-10-15
088000968623378plant Implant System8dent Inc.NHA2026-10-15
088000968688728plant Implant System8dent Inc.NHA2026-10-15
07290114710756prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710787prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710800prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710831prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114710848prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114711654prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114711661prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712026prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712170prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712651prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14
07290114712668prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-14