Custom I Q CIQA

GUDID D798CIQA0

INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is the Part A of the two part system.

RELIANCE ORTHODONTIC PRODUCTS INC

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set
Primary Device IDD798CIQA0
NIH Device Record Key3b8b555d-24eb-4282-a54d-c060aa1cb22c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom I Q
Version Model NumberCIQA
Catalog NumberCIQA
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com
Phone6307734009
Emailpaulgropi@aol.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATION: Store refrigerated (2-8 Degrees C.) Do not expose materials to elevated temperatures.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD798CIQA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHAdhesive, Bracket And Tooth Conditioner, 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 Date2016-07-25

Devices Manufactured by RELIANCE ORTHODONTIC PRODUCTS INC

D79821BTIPS101 - Brush Tips2023-12-21
D798RBTA0 - Tweezers2023-12-21
D798RBTP0 - Tweezers2023-12-21
D798RBX0 - ReliaBox2023-12-21 ReliaBox
D798RBXK0 - ReliaBox2023-12-21 ReliaBox Kit
D7981BEGSSAM0 - Gel Etchant2023-09-27
D7981EGSSAM0 - Gel Etchant2023-09-27
D7981RWX0 - ReliaWax2023-09-27
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.