FC-78

GUDID 04560264557574

NAKANISHI INC.

Dental implant system
Primary Device ID04560264557574
NIH Device Record Key3bc02885-e4cf-44bc-adf6-985450e46f40
Commercial Distribution StatusIn Commercial Distribution
Brand NameFC-78
Version Model NumberFC-78
Company DUNS690710546
Company NameNAKANISHI INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
GS104560264557574 [Primary]

FDA Product Code

EBWController, foot, handpiece and cord

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-10-22
Device Publish Date2018-08-23

Devices Manufactured by NAKANISHI INC.

04589551383993 - Bur Stopper2024-11-21
04589551384006 - Bur Stopper Puller2024-11-21
04560264502963 - PTL Nozzle2024-11-11
04560264502970 - EZ-M4 Adaptor2024-11-11
04589551392063 - EZ SPRAY2024-11-11
04589551391950 - M2052024-10-24
04560264578586 - FX204 M42024-10-24
04589551389391 - Surgic Pro2 OPT2024-10-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.