FDA.reportPublic FDA data

Phase II

Primary DI
D798PJMCF0
Brand
Phase II
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
PJMCF
Catalog number
PJMCF
Device description
Phase II is intended for use in direct and indirect bonding of orthodontic brackets and appliances. This is a chemical cure device.This kit contains:18g Part A Adhesive, 18g Phase II Part B adhesive, 7g Maximum Cure Bonding Resin A with fluoride & 7 gm Maximum Cure Bonding Resin Part B,9g Etchant, mixing pad, spatulas, disposable brushes This is a Fluoride Kit with Maximum Cure Sealants.
Published
2016-08-05
Public version status
Update
Distribution status
Not 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
K895523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894566000MAXIMUM CURE SEALANT WITH FLUORIDEReliance Orthodontic Products, Inc.1989-09-19DYH
K895523000PHASE II ORTHODONTIC ADHESIVEReliance Orthodontic Products, Inc.1989-12-08DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D798PJMCF0PrimaryHIBCC0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
113170088
Device count
1
Kit
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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