FDA.reportPublic FDA data

STARTONE

Primary DI
D873SNANTUPP263A35651
Brand
STARTONE
Company
MASTERDENT LTDA
Model
ANTERIOR UPPER
Device description
ACRILIC TEETH
Published
2021-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K992854000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992854000ARTIFICIAL TEETH (ACRYLIC TEETH)Masterdent Ltda.2000-02-07ELM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D873SNANTUPP263A35651PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage this product in a cool and dry area

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(574)4489345sales@masterdent.com.co

Regulatory Flags#

DUNS number
880330126
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D873ANPOSUPP32MA35651STARTONEPOSTERIOR UPPER2021-06-25
D873SNANTLOW263A2621STARTONEANTERIOR LOWER2021-06-25
D873SNANTLOW263A35651STARTONEANTERIOR LOWER2021-06-25
D873SNANTLOW263A3661STARTONEANTERIOR LOWER2021-06-25
D873SNANTLOW264A2621STARTONEANTERIOR LOWER2021-06-25
D873SNANTLOW264A35651STARTONEANTERIOR LOWER2021-06-25
D873SNANTLOW264A3661STARTONEANTERIOR LOWER2021-06-25
D873SNANTLOW266A2621STARTONEANTERIOR LOWER2021-06-25
D873SNANTLOW266A35651STARTONEANTERIOR LOWER2021-06-25
D873SNANTLOW266A3661STARTONEANTERIOR LOWER2021-06-25
D873SNANTUPP263A2621STARTONEANTERIOR UPPER2021-06-25
D873SNANTUPP263A3661STARTONEANTERIOR UPPER 2021-06-25
D873SNANTUPP264A2621STARTONEANTERIOR UPPER2021-06-25
D873SNANTUPP264A35651STARTONEANTERIOR UPPER2021-06-25
D873SNANTUPP264A3661STARTONEANTERIOR UPPER2021-06-25
D873SNANTUPP266A2621STARTONEANTERIOR UPPER2021-06-25
D873SNANTUPP266A35651STARTONEANTERIOR UPPER2021-06-25
D873SNANTUPP266A3661STARTONEANTERIOR UPPER2021-06-25
D873SNPOLOW32MA2621STARTONEPOSTERIOR LOWER 2021-06-25
D873SNPOSLOW30MA2621STARTONEPOSTERIOR LOWER2021-06-25

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