Self Etching primer SEPPRO

GUDID D798SEPPRO0

The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.S.E.P Starter Kit – Ref# SEPPROS.E.P. Refill Cartridge -Ref# SEPR Light Impervious Mixing Well – Ref# SEPW Microbrushes -Ref# MB S.E.P Dispenser -Ref# SEPD

RELIANCE ORTHODONTIC PRODUCTS INC

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Primary Device ID	D798SEPPRO0
NIH Device Record Key	289ec8fd-c88f-441b-8f9d-322c26030db8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Self Etching primer
Version Model Number	SEPPRO
Catalog Number	SEPPRO
Company DUNS	113170088
Company Name	RELIANCE ORTHODONTIC PRODUCTS INC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com
Phone	630-773-4009
Email	paulgropi@aol.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, Specify	Between 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798SEPPRO0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K071688

FDA Product Code

KLE	Agent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-08-01

On-Brand Devices [Self Etching primer]

D798SEPR0	The Reliance S.E.P.™ is a self etching primer refill cartridge intended to be used for the pre
D798SEPPRO0	The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of
D798SEPD0	The Reliance S.E.P.™ is a self etching primer dispenser is intended to be used for the deliver
D798SEPC0	The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of