Ultra SEP

GUDID D798USEP2ML0

Ultra SEP 2ML

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive
Primary Device IDD798USEP2ML0
NIH Device Record Key2d257cb7-b25c-47e8-bfc3-4556d1a1730d
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra SEP
Version Model NumberUSEP2ML
Company DUNS113170088
Company NameRELIANCE ORTHODONTIC PRODUCTS 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD798USEP2ML0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-23
Device Publish Date2022-05-13

On-Brand Devices [Ultra SEP]

D798USEPUSAM01 single Unidose Ultra SEP
D798USEP06 ml bottle Ultra SEP
D798USEPRK0Ultra SEP Kit
D798USEP2ML0Ultra SEP 2ML

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