FDA.reportPublic FDA data

GlassLok

Primary DI
D798GLSB0
Brand
GlassLok
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
GLSB
Catalog number
GLSB
Device description
GlassLok is intended for use as a dual cure glass ionomer band cement for use in an orthodontic or dental office.This is the Blue GlassLok Starter KitKit contains: 15g GlassLok Powder, 15g GlassLok Liquid, Spatula, Mixing Pad and Measuring Scoop
Published
2020-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193388000GlassLok Kits, GlassLok Powder, GlassLok LiquidReliance Orthodontic Products, Inc.2020-04-27DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D798GLSB0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature (15-30 Degrees C)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6307734009paulgropi@aol.com

Regulatory Flags#

DUNS number
113170088
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D798EMHAPR0EtchmasterEMHAPR2021-07-13
D798ASK0ASKASKASK2016-07-25
D798ASKU0ASKASKUASKU2016-07-25
D798EMCO20EtchmasterEMCO2EMCO22016-09-09
D798EMGAS0EtchmasterEMGASEMGAS2016-09-03
D798EMHA0EtchmasterEMHAEMHA2016-09-03
D798EMHAR0EtchmasterEMHAREMHAR2016-09-04
D798EMTLL1EtchmasterEMTLLEMTLL2016-09-04
D798EMTLS1EtchmasterEMTLSEMTLS2016-09-04
D798EMTRL1EtchmasterEMTRLEMTRL2016-09-04
D798EMTRS1EtchmasterEMTRSEMTRS2016-09-04
D798USEP0Ultra SEPUSEP2022-03-03
D798PPA10Perfect A SmilePPA1PPA12019-09-10
D798PPD30Perfect A SmilePPD3PPD32019-09-10
D798EL240EtchantEL24EL242016-08-10
D798EL24C0EtchantEL24CEL24C2016-08-10
D798LBMPPF0LIGHT BONDLBMPPFLBMPPF2016-08-03
D798LBPP0Light BondLBPPLBPP2016-08-03
D798LBS30Light BondLBS3LBS32016-08-03
D798LBS3F0Light BondLBS3FLBS3F2016-08-06

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Primary DI, Brand, Company table
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08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
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08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
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08809911118505NuSmile NuCemNUSMILE, LTD.EMA2026-04-14
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