NEW ACE/EFUCERA AC COMBINATION SET

GUDID 04582594094345

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth
Primary Device ID04582594094345
NIH Device Record Key7bb8de75-93ad-4e03-a003-c72d4df9cc33
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEW ACE/EFUCERA AC COMBINATION SET
Version Model NumberTL4L634, W0.5
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
GS104582594094345 [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 Date2021-11-29
Device Publish Date2021-11-20

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

04582594094390O5L634, W0.5
04582594094383S7L1034, W0.5
04582594094376S6L734, W0.5
04582594094369S2S3L28, W0.5
04582594094352TL7L1134, W0.5
04582594094345TL4L634, W0.5
04582594094338T6L734, W0.5
04582594094321T5L732, W0.5
04582594094314T4L430, W0.5
04582594094307T3L630, W0.5
04582594094291T2L230, W0.5

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