GlassLok GLS

GUDID D798GLS0

GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office. Starter Kit contains: 15g GlassLok Powder, 15g GlassLok Liquid, Spatula, Mixing Pad and Measuring Scoop

RELIANCE ORTHODONTIC PRODUCTS INC

Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement
Primary Device IDD798GLS0
NIH Device Record Key25ca6dd5-c047-407f-ad7a-0eaf1085acea
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlassLok
Version Model NumberGLS
Catalog NumberGLS
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 Datefalse
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD798GLS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-25
Device Publish Date2020-05-15

On-Brand Devices [GlassLok]

D798GLSB0GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
D798GLS0GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
D798GLP150GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
D798GLP1000GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
D798GLL25B0GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
D798GLL250GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
D798GLL15B0GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
D798GLL150GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
D798GLEB0GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic
D798GLE0GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic

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