FDA.reportPublic FDA data

WAX DISK

Primary DI
D080XXWAD985M22GRE0
Brand
WAX DISK
Company
YAMAHACHI DENTAL MFG.,CO.
Model
1PC,22MM*98.5MM,GREEN
Published
2023-10-05
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
EBHMaterial, Impression Tray, Resin
EGDWax, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D080XXWAD985M22GRE0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental base plateA foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). 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
00840456206942JMUJMU DENTAL, INCEBH2026-07-09
00840456207024JMUJMU DENTAL, INCEBH2026-07-09
00840456207031JMUJMU DENTAL, INCEBH2026-07-09
00840456207048JMUJMU DENTAL, INCEBH2026-07-09
00840456207055JMUJMU DENTAL, INCEBH2026-07-09
00840456207062JMUJMU DENTAL, INCEBH2026-07-09
00840456207079JMUJMU DENTAL, INCEBH2026-07-09
00840456207086JMUJMU DENTAL, INCEBH2026-07-09
00840456207093JMUJMU DENTAL, INCEBH2026-07-09
00840456207109JMUJMU DENTAL, INCEBH2026-07-09
00840456209332JMUJMU DENTAL, INCEBH2026-07-09
00840456209349JMUJMU DENTAL, INCEBH2026-07-09
00840456209356JMUJMU DENTAL, INCEBH2026-07-09
00840456214138JMUJMU DENTAL, INCEBH2026-07-09
00840456214145JMUJMU DENTAL, INCEBH2026-07-09
00840456214152JMUJMU DENTAL, INCEBH2026-07-09
00840456214169JMUJMU DENTAL, INCEBH2026-07-09
00840456214176JMUJMU DENTAL, INCEBH2026-07-09
00840456214183JMUJMU DENTAL, INCEBH2026-07-09
00840456214190JMUJMU DENTAL, INCEBH2026-07-09
00840456214206JMUJMU DENTAL, INCEBH2026-07-09
00840456214213JMUJMU DENTAL, INCEBH2026-07-09
00840456214220JMUJMU DENTAL, INCEBH2026-07-09
00840456223680JMUJMU DENTAL, INCEBH2026-07-09
00840456223697JMUJMU DENTAL, INCEBH2026-07-09
00840456223703JMUJMU DENTAL, INCEBH2026-07-09
00840456223710JMUJMU DENTAL, INCEBH2026-07-09
00840456223727JMUJMU DENTAL, INCEBH2026-07-09
00840456223734JMUJMU DENTAL, INCEBH2026-07-09
00840456223741JMUJMU DENTAL, INCEBH2026-07-09