FDA.reportPublic FDA data

Excel

Primary DI
D798ERJB0
Brand
Excel
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
ERJB
Catalog number
ERJB
Device description
Excel is intended for use as an orthodontic bonding adhesive for appliances. This is a12g Excel Regular Adhesive paste B in a jar.
Published
2016-08-10
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
K875141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K875141000EXCEL REGULAR SETReliance Orthodontic Products, Inc.1988-02-26DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D798ERJB0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket adhesiveA bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00 Store 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
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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08809262957082OrthoFit AlignerSpident Co., Ltd.DYH2026-10-29
00197998073557SolventumSolventum Orthodontics CorporationDYH2026-10-25
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00197998063213SolventumSolventum Orthodontics CorporationDYH2026-10-24
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