FDA.reportPublic FDA data

Zirlux

Primary DI
00304040023457
Brand
Zirlux
Company
HENRY SCHEIN, INC.
Model
9011260
Catalog number
9011260
Device description
ZIRLUX ACETAL MILLING DISC
Published
2016-09-24
Public version status
Update
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
EHPCLASP, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHPClasp, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040023457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040023457003040400234573040400234570304040023457

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
Height20Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00n/a
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
J01810170J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810180J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810190J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810201J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810210J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810220J-Clasp oblique Scheu-Dental GmbHEHP2024-11-19
J01810230JM-ClaspScheu-Dental GmbHEHP2024-11-19
J01810260T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810270T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810470J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810480J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01820480SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820490SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820500SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820510SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820520SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820530SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820550Arrow ClaspScheu-Dental GmbHEHP2024-11-19
J01820560Arrow ClaspScheu-Dental GmbHEHP2024-11-19
J01821040Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821050Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821060Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821070Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821080Adams ClaspScheu-Dental GmbHEHP2024-11-19
J01821090Adams ClaspScheu-Dental GmbHEHP2024-11-19
00000008857972RMORmo, Inc.EHP2024-08-12
D772198150BALL CLASPS 2000 AMERICAN TOOTH INDUSTRIESEHP2023-08-30
D772ATI0131981560BALL CLASP 2000AMERICAN TOOTH INDUSTRIESEHP2023-08-30
D772ATI198140BALL CLASPS 2000AMERICAN TOOTH INDUSTRIESEHP2023-08-30
H66810091500ItsoClearKeystone IndustriesEHP2022-11-30