I-FIX Angled Type ScanBody Screw

GUDID 08800053064743

I-FIX Angled Type ScanBody Screw (DFSBS)

DENTIS CO. ,LTD

Dental implant abutment analog, scanning
Primary Device ID08800053064743
NIH Device Record Key4f4a8bbd-e873-4e78-b314-b93c5e30faeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-FIX Angled Type ScanBody Screw
Version Model NumberDFSBS
Company DUNS694721181
Company NameDENTIS CO. ,LTD
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800053064743 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800053064743]

Moist Heat or Steam Sterilization


[08800053064743]

Moist Heat or Steam Sterilization


[08800053064743]

Moist Heat or Steam Sterilization


[08800053064743]

Moist Heat or Steam Sterilization


[08800053064743]

Moist Heat or Steam Sterilization


[08800053064743]

Moist Heat or Steam Sterilization


[08800053064743]

Moist Heat or Steam Sterilization


[08800053064743]

Moist Heat or Steam Sterilization


[08800053064743]

Moist Heat or Steam Sterilization


[08800053064743]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-26
Device Publish Date2024-11-18

Devices Manufactured by DENTIS CO. ,LTD

08800053053662 - Aqua Tip2024-12-25 Aqua Tip (DSSAT31)
08800053053679 - Aqua Tip2024-12-25 Aqua Tip (DSSAT41)
08800053064729 - I-FIX Angled Type ScanBody2024-11-26 I-FIX Angled Type ScanBody (DFASBS)
08800053064736 - I-FIX Angled Type ScanBody2024-11-26 I-FIX Angled Type ScanBody (DFASBL)
08800053064743 - I-FIX Angled Type ScanBody Screw2024-11-26I-FIX Angled Type ScanBody Screw (DFSBS)
08800053064743 - I-FIX Angled Type ScanBody Screw2024-11-26 I-FIX Angled Type ScanBody Screw (DFSBS)
08800053064750 - I-FIX Angled Type ScanBody2024-11-26 I-FIX Angled Type ScanBody (DFASBSS)
08800053064767 - I-FIX Angled Type ScanBody2024-11-26 I-FIX Angled Type ScanBody (DFASBLS)
08800053093743 - S250 Series(Ceiling, Mobile)2024-11-07 AC 100-240V, 50/60HZ, 61-94VA

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