Self Etching Primer SEPD

GUDID D798SEPD0

The Reliance S.E.P.™ is a self etching primer dispenser is intended to be used for the delivery of the primer in preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.

RELIANCE ORTHODONTIC PRODUCTS INC

Dental etching solution Dental etching solution
Primary Device IDD798SEPD0
NIH Device Record Key70768626-81aa-4dab-b7ae-c167de7ad387
Commercial Distribution StatusIn Commercial Distribution
Brand NameSelf Etching Primer
Version Model NumberSEPD
Catalog NumberSEPD
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone630-773-4009
Emailpaulgropi@aol.com
Phone630-773-4009
Emailpaulgropi@aol.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *store in ambient conditions
Special Storage Condition, SpecifyBetween 0 and 0 *store in ambient conditions

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD798SEPD0 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-01

On-Brand Devices [Self Etching Primer]

D798SEPR0The Reliance S.E.P.™ is a self etching primer refill cartridge intended to be used for the pre
D798SEPPRO0The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of
D798SEPD0The Reliance S.E.P.™ is a self etching primer dispenser is intended to be used for the deliver
D798SEPC0The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of

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