FDA.reportPublic FDA data

Breeze RMGI

Primary DI
00195062159794
Brand
Breeze RMGI
Company
Kerr Corporation
Model
N98
Device description
Breeze RMGI Cement - 1 Cement syringe and 12 Mixing Tips
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195062159794PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195062159794001950621597941950621597940195062159794

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
800-537-7123kerrcustcare@kavokerr.com

Regulatory Flags#

DUNS number
199354556
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
00195062159787BreezeN97E2026-10-27
00195062160332Build-It FRN32AA2026-10-27
00195062160349Build-It FRN32AB2026-10-27
00195062160356Build-It FRN32AC2026-10-27
00195062160363Build-It FRN32AD2026-10-27
00195062160370Build-It FRN32AE2026-10-27
00195062160387Build-It FRN32FS2026-10-27
00195062160394Build-It FRN32FSA2026-10-27
00195062160400Build-It FRN32FSB2026-10-27
00195062160417Build-It FRN32FSC2026-10-27
00195062160424Build-It FRN32FSD2026-10-27
00195062160431Build-It FRN32FA2026-10-27
00195062160448Build-It FRN32FB2026-10-27
00195062160455Build-It FRN32FC2026-10-27
00195062160462Build-It FRN32FD2026-10-27
00195062160479Build-It FRN32FE2026-10-27
00195062160486Build-It FRN32F2026-10-27
00195062160493Build-It FRN322026-10-27
00841396116285NX333642336422016-08-01
10814978021267Build-It FRN32FA2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195062159787BreezeKerr CorporationEMA2026-10-27
00197998079917Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079955Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079962Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079986Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998079993Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998080005Solventum™ Durelon™Solventum Germany GmbHEMA2026-10-08
00197998099984Solventum™ RelyX™Solventum Germany GmbHEMA2026-10-08
00197998226724Solventum™ Protemp™Solventum Germany GmbHEMA2026-10-08
00810118108082NuSmile BioCemNUSMILE, LTD.EMA2026-09-22
00766054002956CEMPOWERESSENTIAL DENTAL SYSTEMS, INC.EMA2026-09-21
00195062162565Cement-ItKerr CorporationEMA2026-07-29
00195062162572Cement-ItKerr CorporationEMA2026-07-29
00195062162589Cement-ItKerr CorporationEMA2026-07-29
08809911118529NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08809911118550NuSmile NuCemNUSMILE, LTD.EMA2026-07-21
08806383591737DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591751DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591775DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591959DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591966DIA-CEMDiaDent Group InternationalEMA2026-07-20
08806383591973DIA-CEMDiaDent Group InternationalEMA2026-07-20
04548162300836ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300843ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300850ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162300867ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
04548162344113ResiCem EXSHOFU DENTAL CORPORATIONEMA2026-07-04
08809262953602EsCemSpident Co., Ltd.EMA2026-04-29
08809262953619EsCemSpident Co., Ltd.EMA2026-04-29
08809262953626EsCemSpident Co., Ltd.EMA2026-04-29