FDA.reportPublic FDA data

Hiflex Modelling Wax

Primary DI
D967130030
Brand
Hiflex Modelling Wax
Company
PREVEST DENPRO LIMITED
Model
24 sheets 500g
Catalog number
13003
Published
2022-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
D967130030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture trial fabrication waxA material made primarily of wax, intended to be used in the dental laboratory to manufacture a trial denture/denture base. It is not intended to be used as an anatomical impression material nor is it intended to be used to manufacture a final dental prosthesis/appliance. It is commonly supplied in sheets and may be referred to as denture sheet wax. This is a single-patient, reusable device.

Regulatory Flags#

DUNS number
859546940
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D967410010Rotoflex Gold files triangular cross section 21mm pack of six410012026-04-29
D967410020Rotoflex Gold files triangular cross section 25mm pack of six410022026-04-29
D967410030Rotoflex Gold files triangular cross section 31mm pack of six410032026-04-29
D967410040Rotoflex Gold files triangular cross section 17/0421mm pack of six410042026-04-29
D967410050Rotoflex Gold files triangular cross section 17/0425mm pack of six410052026-04-29
D967410060Rotoflex Gold files triangular cross section 20/0421mm pack of six410062026-04-29
D967410070Rotoflex Gold files triangular cross section 20/0425mm pack of six410072026-04-29
D967410080Rotoflex Gold files triangular cross section 25/0421mm pack of six410082026-04-29
D967410090Rotoflex Gold files triangular cross section 25/0425mm pack of six410092026-04-29
D967410100Rotoflex Gold files triangular cross section 30/0421mm pack of six410102026-04-29
D967410110Rotoflex Gold files triangular cross section 30/0425mm pack of six410112026-04-29
D967410120Rotoflex Gold files triangular cross section 35/0421mm pack of six410122026-04-29
D967410130Rotoflex Gold files triangular cross section 35/0425mm pack of six410132026-04-29
D967410140Rotoflex Gold files triangular cross section 40/0421mm pack of six410142026-04-29
D967410150Rotoflex Gold files triangular cross section 40/0425mm pack of six410152026-04-29
D967410160Rotoflex Gold files triangular cross section 20/0621mm pack of six410162026-04-29
D967410170Rotoflex Gold files triangular cross section 20/0625mm pack of six410172026-04-29
D967410180Rotoflex Gold files triangular cross section 25/0621mm pack of six410182026-04-29
D967410190Rotoflex Gold files triangular cross section 25/0625mm pack of six410192026-04-29
D967410200Rotoflex Gold files triangular cross section 30/0621mm pack of six410202026-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456200193JMUJMU DENTAL, INCEGD2026-06-22
00840456224144JMUJMU DENTAL, INCEGD2026-06-22
00840456224151JMUJMU DENTAL, INCEGD2026-06-22
00840456224168JMUJMU DENTAL, INCEGD2026-06-22
00840456224175JMUJMU DENTAL, INCEGD2026-06-22
00840456224182JMUJMU DENTAL, INCEGD2026-06-22
EYET6530500M0 Sculp. Wax SPECIAL-Summer-Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET65505000 Sculp. Wax SPEZIAL winter Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6550500M0 Sculp. Wax SPEZIAL winter Pink, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET66005000 Sculp. Wax SUPERPINK elastic, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6600500M0 Sculp. Wax SUPERPINK elastic, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET68000000SOLIDUS 80, base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6800000M0SOLIDUS 80, base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET68400000 SOLIDUS 84 base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
EYET6840000M0 SOLIDUS 84 base plate wax sheet, SampleYeti Dentalprodukte GmbHEGD2026-05-20
D800ZBAC6705WHI0Printer Resin Try-In & Burnout White (500g)ZIRKONZAHN SRLEGD2026-05-20
EYET60500600Bite regist. Metal foil wax, brownYeti Dentalprodukte GmbHEGD2026-05-11
EYET61001000Performed Bite rims, soft yellow “lemon” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6100100M0Performed Bite rims, soft yellow “lemon” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET61101000 Performed Bite rims, hard, pink “strawb.”Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6110100M0 Performed Bite rims, hard, pink “strawb.”,Sample Yeti Dentalprodukte GmbHEGD2026-05-11
EYET61204900Bite wax sticks, soft, yellow, “lemon” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6120490M0Bite wax sticks, soft, yellow, “lemon” ,SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET61301000Performed Bite rims, medium “orange”, SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET6130100M0Performed Bite rims, medium “orange”, SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET61304900Bite wax sticks, hard, pink, “strawb.” Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6130490M0Bite wax sticks, hard, pink, “strawb.” , SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET61401000Preformed Bite rims, very hard, pink Yeti Dentalprodukte GmbHEGD2026-05-11
EYET6140100M0Preformed Bite rims, very hard, pink Yeti Dentalprodukte GmbHEGD2026-05-11
EYET61404900 Bite wax sticks, medium, gree, “apple” Yeti Dentalprodukte GmbHEGD2026-05-11