FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040005569
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1048757
Catalog number
1048757
Device description
Soft Reline Material Refill
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

Product Codes#

Code, Name table
CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040005569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040005569003040400055693040400055690304040005569

GMDN Terms#

Term, Definition table
TermDefinition
Denture reliner, soft, professionalA denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842326128095DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128101DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128118DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128125DuraflexThe Myerson Company LimitedEBI2026-05-26
00815967025917RodinPac-Dent, Inc.EBI2026-03-23
00815967029342RodinPac-Dent, Inc.EBI2026-03-23
00815967029359RodinPac-Dent, Inc.EBI2026-03-23
00815967029366RodinPac-Dent, Inc.EBI2026-03-23
00815967029373RodinPac-Dent, Inc.EBI2026-03-23
06971437942314UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942321UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942338UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942352UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942376UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942383UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942390UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942406UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942413UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942192UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942208UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942215UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942222UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942239UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942246UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942253UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942260UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942277UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942284UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942291UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942307UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04