SHADE GUIDE NS

GUDID D080SDGNS17PCSX17C0

YAMAHACHI DENTAL MFG.,CO.

Dental shade guide
Primary Device IDD080SDGNS17PCSX17C0
NIH Device Record Key423d7a92-fb34-4b92-8f20-c97967bb73fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHADE GUIDE NS
Version Model NumberSHADE GUIDE NS,17PCS,17C
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
HIBCCD080SDGNS17PCSX17C0 [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 Date2025-12-03
Device Publish Date2025-11-25

Devices Manufactured by YAMAHACHI DENTAL MFG.,CO.

D080SDGNS17PCSX17C0 - SHADE GUIDE NS2025-12-03
D080SDGNS17PCSX17C0 - SHADE GUIDE NS2025-12-03
D080XXPMD985M18VPN0 - PMMA DISK2025-08-11
D080XXPMD101M13PV80 - PMMA DISK2025-02-11
D080XXPMD101M20PV80 - PMMA DISK2025-02-11
D080XXPMD95MM20PV80 - PMMA DISK2025-02-11
D080XXPMD95MM22PV80 - PMMA DISK2025-02-11
D080XXPMD95MM25PV80 - PMMA DISK2025-02-11
D080XXPMD95MM30PV80 - PMMA DISK2025-02-11

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