FDA.reportPublic FDA data

SHADE GUIDE AC

Primary DI
D080SDGAC17PCSX17C0
Brand
SHADE GUIDE AC
Company
YAMAHACHI DENTAL MFG.,CO.
Model
SHADE GUIDE AC,17PCS,17C
Published
2025-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060507000VALPLAST YAMAHACHI TEETHValplast Intl. Corp.2006-04-07ELM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D080SDGAC17PCSX17C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental shade guideA device used to determine the correct shade (colour) of filling materials, artificial crowns, and teeth to match the patient's dentition.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
693430001
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0804SNEAZ107ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S4L432,UL,D32026-08-25
D0804SNEAZ129ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,A3.52026-08-25
D0804SNEAZ129ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,A22026-08-25
D0804SNEAZ129ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,A32026-08-25
D0804SNEAZ129ULXB20NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,B22026-08-25
D0804SNEAZ129ULXB30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,B32026-08-25
D0804SNEAZ129ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S5L634,UL,D32026-08-25
D0804SNEAZ144ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S6L734,UL,W0.52026-08-25
D0804SNEAZ144ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S6L734,UL,A12026-08-25
D0804SNEAZ144ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S6L734,UL,A22026-08-25
D0804SNEAZ144ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S6L734,UL,A32026-08-25
D0804SNEAZ144ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S6L734,UL,B12026-08-25
D0804SNEAZ155ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S7L1034,UL,A12026-08-25
D0804SNEAZ155ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S7L1034,UL,A22026-08-25
D0804SNEAZ155ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S7L1034,UL,A32026-08-25
D0804SNEAZ155ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S7L1034,UL,B12026-08-25
D0804SNEAZ167ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S8L1136,UL,A3.52026-08-25
D0804SNEAZ167ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S8L1136,UL,A22026-08-25
D0804SNEAZ167ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S8L1136,UL,A32026-08-25
D0804SNEAZ167ULXA40NEW ACE/EFUCERA AC 4 PLATE SAMPLE28*1SETS,S8L1136,UL,A42026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D0804SNEAZ107ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXB20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXB30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ129ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ144ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ155ULXB10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ167ULXA40NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ170ULXD30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULA350NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULW050NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULXA10NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULXA20NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25
D0804SNEAZ171ULXA30NEW ACE/EFUCERA AC 4 PLATE SAMPLEYAMAHACHI DENTAL MFG.,CO.ELM2026-08-25