CROWN PX-A/EFUCERA PX-P 4 PLATE SAMPLE

GUDID 04582275968514

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth
Primary Device ID04582275968514
NIH Device Record Key81b5799d-9590-4947-bc91-8ac25f774811
Commercial Distribution StatusIn Commercial Distribution
Brand NameCROWN PX-A/EFUCERA PX-P 4 PLATE SAMPLE
Version Model NumberS51N4230, A2
Company DUNS693430001
Company NameYAMAHACHI DENTAL MFG.,CO.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104582275968514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELMDenture, Plastic, Teeth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-02-06

Devices Manufactured by YAMAHACHI DENTAL MFG.,CO.

D080XXPMD95MM1535M0 - PMMA DISK2024-09-20
D080XXPMD95MM15A1M0 - PMMA DISK2024-09-20
D080XXPMD95MM15A2M0 - PMMA DISK2024-09-20
D080XXPMD95MM15A3M0 - PMMA DISK2024-09-20
D080XXPMD95MM15A4M0 - PMMA DISK2024-09-20
D080XXPMD95MM15B1M0 - PMMA DISK2024-09-20
D080XXPMD95MM15B2M0 - PMMA DISK2024-09-20
D080XXPMD95MM15B3M0 - PMMA DISK2024-09-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.