NAPERCE

GUDID 04582276038209

YAMAHACHI DENTAL MFG.,CO.

Resin artificial teeth
Primary Device ID04582276038209
NIH Device Record Key632c4cdf-b6b0-4352-86ff-3c42f60b600b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNAPERCE
Version Model NumberM30L, B3
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
GS104582276038209 [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 Date2018-01-18

On-Brand Devices [NAPERCE]

04582276040639M36L, W0.5
04582276040622M36U, W0.5
04582276040608M36L, D4
04582276040592M36U, D4
04582276040578M36L, D3
04582276040561M36U, D3
04582276040547M36L, D2
04582276040530M36U, D2
04582276040516M36L, C4
04582276040509M36U, C4
04582276040486M36L, C3
04582276040479M36U, C3
04582276040455M36L, C2
04582276040448M36U, C2
04582276040424M36L, C1
04582276040417M36U, C1
04582276040394M36L, B4
04582276040387M36U, B4
04582276040363M36L, B3
04582276040356M36U, B3
04582276040332M36L, B2
04582276040325M36U, B2
04582276040301M36L, B1
04582276040295M36U, B1
04582276040271M36L, A4
04582276040264M36U, A4
04582276040240M36L, A3.5
04582276040233M36U, A3.5
04582276040219M36L, A3
04582276040202M36U, A3
04582276040189M36L, A2
04582276040172M36U, A2
04582276040158M36L, A1
04582276040141M36U, A1
04582276040127M34L, W0.5
04582276040110M34U, W0.5
04582276040059M34L, D4
04582276040042M34U, D4
04582276040028M34L, D3
04582276040011M34U, D3
04582276039992M34L, D2
04582276039985M34U, D2
04582276039961M34L, C4
04582276039954M34U, C4
04582276039930M34L, C3
04582276039923M34U, C3
04582276039909M34L, C2
04582276039893M34U, C2
04582276039879M34L, C1
04582276039862M34U, C1

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