FDA.reportPublic FDA data

STARVIT

Primary DI
D873SVANTLOW1
Brand
STARVIT
Company
MASTERDENT LTDA
Model
ANTERIOR LOWER
Published
2017-03-10
Public version status
Update
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
D873SVANTLOW1PrimaryHIBCC0

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
D873SNANTUPP263A35651STARTONEANTERIOR 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EPOLCL01A2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01A9CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01B4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01C4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01D4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL01L3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02A9CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02B4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C1CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C3CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02C4CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10
EPOLCL02D2CROSS LINKED 2POLIDENT d.o.o.ELM2021-06-10