NEW ACE/EFUCERA AC FULL SET

GUDID 04582275871739

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth
Primary Device ID04582275871739
NIH Device Record Keydac25442-6104-4bc1-97c3-2a0f13d65338
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEW ACE/EFUCERA AC FULL SET
Version Model NumberO5L634, A3
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
GS104582275871739 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-07
Device Publish Date2021-04-29

On-Brand Devices [NEW ACE/EFUCERA AC FULL SET]

04582275871746O5L634, B1
04582275871739O5L634, A3
04582275871722O4S4L32, B1
04582275871715O4S4L32, A3
04582275871708O3L330, B1
04582275871692O3L330, A3
04582275871685O2S3L28, B1
04582275871678O2S3L28, A3
04582275871661SS3S4L30, B1
04582275871654SS2S3L28, B1
04582275871647SS2S3L28, A3
04582275871630S5L634, B1
04582275871623S5L634, A3
04582275871616S4L432, B1
04582275871609S4L432, A3
04582275871593S3S4L30, B1
04582275871586S3S4L30, A3
04582275871579S2S3L28, B1
04582275871562S2S3L28, A3
04582275871555TL6L934, A3
04582275871548TL4L634, A3
04582275871531T3L630, B1
04582275871524T2L230, B1
04582275871517T1L228, B1

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