FDA.report

Zirlux

Primary DI
00304040151549
Brand
Zirlux
Company
HENRY SCHEIN, INC.
Model
9012706
Catalog number
9012706
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

Related Records

Product Codes

CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions

SubmissionSupplement
K172407000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K172407000DuracetalThe Myerson Company Limited2017-11-02EBI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040151549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040151549003040401515493040401515490304040151549

GMDN Terms

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

TypeValueUnit
Height25Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0193 Degrees Celsius

Sterilization Methods

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

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Primary DIBrandModelCatalogPublished
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00304040195420Henry Schein570582357058232026-03-13
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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

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