FDA.reportPublic FDA data

iphysio®

Primary DI
03700977507522
Brand
iphysio®
Company
EUROTEKNIKA
Model
CDINCC
Catalog number
CDINCC
Device description
NCC iPhysio Starter Kit
Published
2025-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
03700977507522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700977507522037009775075223700977507522

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
382690691
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
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
03700977500004iphysio® Profile DesignerZSC45_I.C3ZSC45_I.C32025-05-23
03700977500011iphysio® Profile DesignerZSC45_I.C1ZSC45_I.C12025-05-23
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
07899878068181NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068198NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068211NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068228NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068235NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068242NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068259NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07392532151156Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532151163Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192425Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192449Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192456Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192463Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192470Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192487Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532186622N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532186639N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216343ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216350ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216367ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216374ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216381ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216398ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216404ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216411ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216428ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216435ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216442ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216459ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216466ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18