iphysio® IE_U.A1

GUDID 03700977506402

Universal Try-in Abutment Size A1

EUROTEKNIKA

Dental implant system
Primary Device ID03700977506402
NIH Device Record Keyf81d2b3c-4c12-4fe5-bb3d-f454c8865589
Commercial Distribution StatusIn Commercial Distribution
Brand Nameiphysio®
Version Model NumberIE_U.A1
Catalog NumberIE_U.A1
Company DUNS382690691
Company NameEUROTEKNIKA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter
Height1 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103700977506402 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


[03700977506402]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-02
Device Publish Date2025-05-23

On-Brand Devices [iphysio®]

03700977511888Universal Try-in Abutment Size A2
03700977511871Universal Try-in Abutment Size A4
03700977511857Universal Try-in Abutment Size B2
03700977511840Universal Try-in Abutment Size B4
03700977511826Universal Try-in Abutment Size C2
03700977511819Universal Try-in Abutment Size C4
03700977511796Universal Try-in Abutment Size D1
03700977511789Universal Try-in Abutment Size D2
03700977511772Universal Try-in Abutment Size D3
03700977511765Universal Try-in Abutment Size D4
03700977511475iphysio® Profile Designer Healing Abutment Size B4 and compatible screw
03700977511468iphysio® Profile Designer Healing Abutment Size D1 and compatible screw
03700977511345Temporary Abutment and screw for NCCR iphysio
03700977506402Universal Try-in Abutment Size A1
03700977506396Universal Try-in Abutment Size A3
03700977506389Universal Try-in Abutment Size B1
03700977506372Universal Try-in Abutment Size B3
03700977506365Universal Try-in Abutment Size C1
03700977506358Universal Try-in Abutment Size C3
03700977505504Universal Try-in Abutment Kit
03700977505436iphysio® Profile Designer Healing Abutment Size B3 and compatible screw
03700977505429Temporary Abutment and screw for NCCN iphysio
03700977501292Temporary Abutment and screw for SBL iphysio
03700977500103Temporary Abutment and screw for ZSC iphysio

Trademark Results [iphysio]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IPHYSIO
IPHYSIO
79388707 not registered Live/Pending
EUROTEKNIKA
2023-11-21

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.