FDA.reportPublic FDA data

Zirlux

Primary DI
00304040151525
Brand
Zirlux
Company
HENRY SCHEIN, INC.
Model
9012704
Catalog number
9012704
Device description
ZIRLUX ACETAL MILLING DISC
Published
2021-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172407000DuracetalThe Myerson Company Limited2017-11-02EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040151525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040151525003040401515253040401515250304040151525

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height15Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0193 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
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