FDA.reportPublic FDA data

iphysio®

Primary DI
03700977506402
Brand
iphysio®
Company
EUROTEKNIKA
Model
IE_U.A1
Catalog number
IE_U.A1
Device description
Universal Try-in Abutment Size A1
Published
2025-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700977506402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700977506402037009775064023700977506402

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height1Millimeter

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
Premarket exempt
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
03700977507522iphysio®CDINCCCDINCC2025-05-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03