FDA.report

Henry Schein

Primary DI
00304040023716
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9007877
Catalog number
9007877
Device description
ZirluxTemp Multi PMMA100x20mm
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
true

Related Records

Product Codes

CodeName
EGDWAX, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00304040023716PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040023716003040400237163040400237160304040023716

GMDN Terms

TermDefinition
Dental cusp, temporaryA temporary dental onlay designed to provide an artificial projection on the chewing surface of the tooth to achieve a proper bite (occlusal harmony), either between natural teeth or between natural teeth and an artificial denture. It is typically made of stainless steel, a precious metal alloy [e.g., gold (Au), platinum (Pt)], porcelain, or a composite resin.

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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00304040187616Zirlux920006192000612026-02-04
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00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

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