FDA.reportPublic FDA data

Bite Occlusion Rims - Wax

Primary DI
D8453003101
Brand
Bite Occlusion Rims - Wax
Company
Denplus Inc
Model
3003101
Catalog number
3003101
Device description
Bite Occlusion Rims - Wax, Pink, 100 units
Published
2021-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
D8453003101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bite registration rim waxA dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
202016064
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8451001100DP9710011001001102018-04-30
D8451001102DP97100110210011022018-04-30
D8451001107DP97100110710011072018-04-30
D8451001116DP97100111610011162018-04-30
D8451001200DP97100120010012002018-04-30
D8451001202DP97100120210012022018-04-30
D8451001207DP97100120710012072018-04-30
D8451001216DP97100121610012162018-04-30
D8451001300DP97100130010013002018-04-30
D8451001302DP97100130210013022018-04-30
D8451001303DP97100130310013032018-04-30
D8451001307DP97100130710013072018-04-30
D8451001309DP97100130910013092018-04-30
D8451001316DP97100131610013162018-04-30
D8451011101IMPACT-PLUS101110110111012018-04-30
D8451011102IMPACT-PLUS101110210111022018-04-30
D8451011103IMPACT-PLUS101110310111032018-04-30
D8451011104IMPACT-PLUS101110410111042018-04-30
D8451011105IMPACT-PLUS101110510111052018-04-30
D8451011107IMPACT-PLUS101110710111072018-04-30

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