Light Cure Retainer LCRET

GUDID D798LCRET0

L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers, creation of occlusal buildups and for retention of thermoplastic aligners. This kit contains 20g LCR paste tips, 2 X 3cc Light Bond Sealants, 1 X 23g etchant and mixing accessories.

RELIANCE ORTHODONTIC PRODUCTS INC

Orthodontic bracket adhesive
Primary Device IDD798LCRET0
NIH Device Record Key9910f4bd-dbc5-46c0-8f1e-68e5bb032c5e
Commercial Distribution Discontinuation2019-05-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameLight Cure Retainer
Version Model NumberLCRET
Catalog NumberLCRET
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 Kittrue
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
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com
Phone6307734009
Emailregulatory@relianceorthodontics.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature (15-30 Degrees C) Avoid excessive heat.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD798LCRET0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHAdhesive, Bracket And Tooth Conditioner, Resin
EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-09
Device Publish Date2016-08-08

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D798LCREPAS0L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic
D798LCR150L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic
D798LCR0L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic
D7981LCR150L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic

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