FDA.reportPublic FDA data

ResinKeeper

Primary DI
D77990110114
Brand
ResinKeeper
Company
COSMEDENT, INC.
Model
901101
Published
2020-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D77990110114PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113911689
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D7796611010PorcelEtch6611016611012016-09-22
D7796631010PorcelEtch6631016631012016-09-22
D7796631020PorcelEtch6631026631022016-09-22
D7796631030CompositeEtch6631036631032016-09-22
D7796631040PorcelEtch6631046631042016-09-22
D7796040153Prevue Refill Kit6040156040152016-09-22
D7799060000Enamelize9060009060002016-09-22
D7799061010Enamelize9061019061012016-09-22
D7799061040Porcelize9061049061042016-09-22
D7799061050Porcelize9061059061052016-09-22
D7799061021Porcelize Kit9061022020-01-21
D7796541030Complete Dual-Cure Catalyst6541036541032016-09-22
D7796541040Complete Unfilled Resin6541046541042016-09-22
D7796061A20Renamel® Microhybrid6061A26061A22016-09-22
D7796062A21Renamel® Microhybrid6062A26062A22016-09-22
D7796062B21Renamel® Microhybrid6062B26062B22016-09-22
D7796062MI1Renamel® Microhybrid6062MI6062MI2016-09-22
D779100ROD1IPC Off-Angle Long100ROD2023-09-12
D77970110W0Renamel® Flowable Microhybrid70110W70110W2016-09-22
D7797011A10Renamel® Flowable Microhybrid7011A17011A12016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078100196HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100202HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100226HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100233HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100240HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100332IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100349XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078101896Jones UnionEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078102770IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078103098IO FiX TrioEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078107935XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078108253APEXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109359IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109373CarpalFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110003CompressX2EXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110102AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110133AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112182Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112199Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112205Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078112250Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114025Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114636Axis BeamsEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078114643Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078115305Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078115770Omni MTPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116661Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116678Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078116685Omni PlatingEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078117200KinematX TotalEXTREMITY MEDICAL, LLCFSM2026-11-02