Luvis Chair (LC700C)

GUDID 08800053083249

Luvis Chair is intended to supply power to and serve as a base for dental devices and accessories. This Device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.

DENTIS CO. ,LTD

Dental chair, electric
Primary Device ID08800053083249
NIH Device Record Key420456d7-e8ec-4ccf-aa7d-ecf37a3a6203
Commercial Distribution StatusIn Commercial Distribution
Brand NameLuvis Chair (LC700C)
Version Model NumberLC700C
Company DUNS694721181
Company NameDENTIS CO. ,LTD
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 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
GS108800053083249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLCChair, Dental, With Operative Unit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


[08800053083249]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-27
Device Publish Date2024-09-19

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