FDA.reportPublic FDA data

Maximum Cure

Primary DI
D798MC20AF0
Brand
Maximum Cure
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
MC20AF
Catalog number
MC20AF
Device description
Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appliances. This is a Maximum Cure Part A, 20 gm bottle. Product contains Fluoride.
Published
2016-08-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
D798MC20AF0PrimaryHIBCC0

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.

Contacts#

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

Regulatory Flags#

DUNS number
113170088
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998062605SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062612SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062629SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062636SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062643SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062650SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062667SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062674SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062766SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062773SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062780SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062797SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062865SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062872SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998062896SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998064739SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998064746SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067891SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067907SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067914SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067921SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067938SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067945SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067952SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067969SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067976SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998067983SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069208SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069215SolventumSolventum Orthodontics CorporationDYH2026-11-04
00197998069222SolventumSolventum Orthodontics CorporationDYH2026-11-04