ELiTEDENT

GUDID 04713909450444

ROLENCE ENTERPRISE INC.

Dental/surgical polymerization lamp
Primary Device ID04713909450444
NIH Device Record Key778aae02-a4d8-4330-99df-66c485c54d3c
Commercial Distribution Discontinuation2021-09-23
Commercial Distribution StatusIn Commercial Distribution
Brand NameELiTEDENT
Version Model NumberQ-6B
Company DUNS656096658
Company NameROLENCE ENTERPRISE 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104713909450444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBZActivator, Ultraviolet, For Polymerization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [ELiTEDENT]

04713909450598Classic / R1
04713909450581PS-25B
04713909450574Classic / Plus
04713909450567Classic / Dual
04713909450550Classic / Dual
04713909450543Classic / Plus
04713909450536PS-25
04713909450529MS-10B
04713909450512MS-10
04713909450444Q-6B
04713909450437Q-6
04713909450420Q-4W
04713909450413Q-4

Trademark Results [ELiTEDENT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ELITEDENT
ELITEDENT
77096151 3389566 Live/Registered
Rolence Enterprise Inc.
2007-01-31

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