FDA.reportPublic FDA data

Porcelain Conditioner

Primary DI
D798PO0
Brand
Porcelain Conditioner
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
PO
Catalog number
PO
Device description
Reliance Porc-Etch™ & Porcelain Conditioner are intended for use in the preparation of glazed dental porcelain for bonding. . Porcelain Conditioner is a silane coupling agent which chemically unites with the silicon in the porcelain and the acrylic in chemical, light cure and dual cure adhesives. 8cc Porcelain Conditioner
Published
2016-08-15
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
K880790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K880790000PORCELAIN PRIMERReliance Orthodontic Products, Inc.1988-04-18DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D798PO0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. 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)

Contacts#

Phone, Email table
PhoneEmail
6307734009paulgropi@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

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Primary DI, Brand, Company table
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08809262957983OrthoFitSpident Co., Ltd.DYH2026-07-14
08809262957990OrthoFitSpident Co., Ltd.DYH2026-07-14
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006522213074463M™ Clarity™3M UNITEK CORPORATIONDYH2026-04-25
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