FDA.reportPublic FDA data

Maximum Cure

Primary DI
D798MCF7AF0
Brand
Maximum Cure
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
MCF7AF
Catalog number
MCF7AF
Device description
Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appliances. 7g Maximum Cure Filled sealant part A with fluoride. This is the filled version of this sealant. This product contains Fluoride.
Published
2016-08-06
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
DYHAdhesive, Bracket And Tooth Conditioner, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894566000MAXIMUM CURE SEALANT WITH FLUORIDEReliance Orthodontic Products, Inc.1989-09-19DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D798MCF7AF0PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store refrigerated (2-8 degrees C) Avoid excessive heat. Allow to reach room temperature prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
630-773-4009paulgropi@aol.com

Regulatory Flags#

DUNS number
113170088
Device count
1
Lot or batch
true
Expiration date on label
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
Primary DIBrandCompanyProduct codePublished
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