FDA.report

Henry Schein

Primary DI
H6581005016
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1005016
Catalog number
1005016
Device description
Preline Calcium Hydroxide Dentin
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H6581005016PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental pulp-capping materialA dental compound designed to cover an exposed or nearly-exposed dental pulp (e.g., due to deep cavities) to provide protection against external influences and to promote healing. This compound does not have dental cement or dental cavity liner intended uses. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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 DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06942201747329FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747398FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747404FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747497FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747589FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747596FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747688FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747695FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747701FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747886FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201747978FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-26
06942201746728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747015FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747114FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747190FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747206FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
06942201747305FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-05-22
08800055726946C&B 5.0 HybridARUM DENTISTRY Co., Ltd.EBG2026-03-10
08800055726953C&B 5.0 HybridARUM DENTISTRY Co., Ltd.EBG2026-03-10
06971437944158UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944165UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944172UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944189UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944196UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
E235DD18B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02