ELiTEDENT

GUDID 04713909450581

ROLENCE ENTERPRISE INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal
Primary Device ID04713909450581
NIH Device Record Key6d025b62-50ca-43b2-ad13-60f2addd9ea5
Commercial Distribution Discontinuation2021-09-23
Commercial Distribution StatusIn Commercial Distribution
Brand NameELiTEDENT
Version Model NumberPS-25B
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104713909450581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELCScaler, Ultrasonic

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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