FDA.reportPublic FDA data

BITE RIM STICK

Primary DI
D080XXBRM11KGL5RED0
Brand
BITE RIM STICK
Company
YAMAHACHI DENTAL MFG.,CO.
Model
50PCS,L,RED
Published
2021-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
D080XXBRM11KGL5RED0PrimaryHIBCC0
04582275712414SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04582275712414045822757124144582275712414

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
693430001
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D080XXTRR05KGXXW050TrinDy Try-In0.5KG,W0.52026-04-27
D080XXTRR05KGXXXA10TrinDy Try-In0.5KG,A12026-04-27
D080XXTRR05KGXXXA20TrinDy Try-In0.5KG,A22026-04-27
D080XXTRRX1KGXXW050TrinDy Try-In1KG,W0.52026-04-27
D080XXTRRX1KGXXXA10TrinDy Try-In1KG,A12026-04-27
D080XXTRRX1KGXXXA20TrinDy Try-In1KG,A22026-04-27
D080XXTRS05KGXXCLE0TrinDy Surgical Guide0.5KG,CLEAR2026-04-27
D080XXTRSX1KGXXCLE0TrinDy Surgical Guide1KG,CLEAR2026-04-27
D080XXTRT05KGXXBLU0TrinDy Tray0.5KG,BLUE2026-04-27
D080XXTRT05KGXXPNK0TrinDy Tray0.5KG,PINK2026-04-27
D080XXTRTX1KGXXBLU0TrinDy Tray1KG,BLUE2026-04-27
D080XXTRTX1KGXXPNK0TrinDy Tray1KG,PINK2026-04-27
D080XXGCO15MLXXXXX0GLOSSY COAT15ML2026-04-10
D080XXPMD101M13VPN0PMMA DISK1PC,13MM*101MM,V PINK2023-10-04
D080XXPMD101M20VPN0PMMA DISK1PC,20MM*101MM,V PINK2023-10-04
D080XXPMD95MM22VPN0PMMA DISK1PC,22MM*95MM,V PINK2023-10-04
D080XXPMD95MM25VPN0PMMA DISK1PC,25MM*95MM,V PINK2023-10-04
D080XXPMD95MM30VPN0PMMA DISK1PC,30MM*95MM,V PINK2023-10-04
D080XXPMD95MM20VPN0PMMA DISK1PC,20MM*95MM,V PINK2023-10-03
D080XXPMD985M1735V0PMMA DISK1PC,17.5MM+17.5MM*98.5MM,A3.5+V PINK2023-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
EYET6140490M0 Bite wax sticks, medium, gree, “apple” ,SampleYeti Dentalprodukte GmbHEGD2026-05-11
EYET6840000SOLIDUS 84Yeti Dentalprodukte GmbHEGD2026-04-13
00840479203324RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-03-12
00840479203331RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-03-12
00840479200552RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23
00840479200569RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23