FDA.reportPublic FDA data

ZCAD TempFix

Primary DI
00304040006764
Brand
ZCAD TempFix
Company
HENRY SCHEIN, INC.
Model
9007913
Catalog number
9007913
Device description
Zirlux Temp PMMA 98x18mm
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

Product Codes#

Code, Name table
CodeName
EGDWAX, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040006764PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040006764003040400067643040400067640304040006764

GMDN Terms#

Term, Definition table
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 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
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

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
00840479203324RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-03-12
00840479203331RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-03-12
00840479200552RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23
00840479200569RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23
06978785665070InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-12-08
10190707193215Orthosil™Ortho Organizers, Inc.EGD2025-10-23
10190707149045Comfort Cover™Ortho Organizers, Inc.EGD2025-10-01
10190707143005Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143012Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143029Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143036Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143043Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143050Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143067Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143074Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143081Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143098Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
E235S3DCR0DentaprintSHOFU DENTAL CORPORATIONEGD2025-08-26
07701126901150Portux 3D Printing Resin CastPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEGD2025-08-11
07701126901228Portux 3D Printing Resin CastPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEGD2025-08-11
00840456207604JMUJMU DENTAL, INCEGD2025-07-15
00840456207611JMUJMU DENTAL, INCEGD2025-07-15
00840456207628JMUJMU DENTAL, INCEGD2025-07-15
00840456207635JMUJMU DENTAL, INCEGD2025-07-15
00840456207642JMUJMU DENTAL, INCEGD2025-07-15
16978785665046InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-07-09
06978785665049InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-07-09
07506338322454ROGSON WAX, MDC Dental MDC DENTALEGD2025-05-16
00190886135498NAG & H Wire Company, Inc.EGD2025-03-31
00190886135559NAG & H Wire Company, Inc.EGD2025-03-31