Rolence

GUDID 04713909450628

ROLENCE ENTERPRISE INC.

Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital Hand-held intraoral dental x-ray system, digital
Primary Device ID04713909450628
NIH Device Record Key26525f76-c147-46ee-a2c1-1489921f6e61
Commercial Distribution StatusIn Commercial Distribution
Brand NameRolence
Version Model NumberXR-01
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
GS104713909450628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EHDUnit, X-Ray, Extraoral With Timer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [Rolence]

04713909450604MS-30 HS
04713909450482Q-LUX
04713909450475CU-80
04713909450468CU-100RLC
04713909450451CU-100A
04713909450628XR-01

Trademark Results [Rolence]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ROLENCE
ROLENCE
75792025 2507821 Dead/Cancelled
ROLENCE ENTERPRISE CO., LTD.
1999-09-02

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