FDA.reportPublic FDA data

iphysio® Profile Designer

Primary DI
03700977500011
Brand
iphysio® Profile Designer
Company
EUROTEKNIKA
Model
ZSC45_I.C1
Catalog number
ZSC45_I.C1
Device description
iphysio® Profile Designer Healing Abutment Size C1 and compatible screw
Published
2025-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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
K232383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232383000iPhysio® SystemEuroteknika2025-03-04NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700977500011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700977500011037009775000113700977500011

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height7.4Millimeter
Length6.6Millimeter
Width7.65Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
382690691
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
03700977511048iphysio® Profile DesignerZSC45_I.B2ZSC45_I.B22025-05-23
03700977507508iphysio®CDIZSCCDIZSC2025-05-27
03700977507515iphysio®CDISBLCDISBL2025-05-27
03700977507522iphysio®CDINCCCDINCC2025-05-27
03700977500004iphysio® Profile DesignerZSC45_I.C3ZSC45_I.C32025-05-23
03700977500028iphysio® Profile DesignerZSC45_I.B3ZSC45_I.B32025-05-23
03700977500035iphysio® Profile DesignerZSC45_I.B1ZSC45_I.B12025-05-23
03700977500042iphysio® Profile DesignerZSC35_I.C3ZSC35_I.C32025-05-23
03700977500059iphysio® Profile DesignerZSC35_I.C1ZSC35_I.C12025-05-23
03700977500066iphysio® Profile DesignerZSC35_I.B3ZSC35_I.B32025-05-23
03700977500073iphysio® Profile DesignerZSC35_I.B1ZSC35_I.B12025-05-23
03700977500080iphysio® Profile DesignerZSC35_I.A3ZSC35_I.A32025-05-23
03700977500097iphysio® Profile DesignerZSC35_I.A1ZSC35_I.A12025-05-23
03700977500103iphysio®ZSC_IPPCZSC_IPPC2025-05-23
03700977501216iphysio® Profile DesignerSBLR_I.C3SBLR_I.C32025-05-23
03700977501223iphysio® Profile DesignerSBLR_I.C1SBLR_I.C12025-05-23
03700977501230iphysio® Profile DesignerSBLR_I.B3SBLR_I.B32025-05-23
03700977501247iphysio® Profile DesignerSBLR_I.B1SBLR_I.B12025-05-23
03700977501254iphysio® Profile DesignerSBLN_I.B3SBLN_I.B32025-05-23
03700977501261iphysio® Profile DesignerSBLN_I.B1SBLN_I.B12025-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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