FDA.report

DAVINCI

Primary DI
D873DAPOSUPP1
Brand
DAVINCI
Company
MASTERDENT LTDA
Model
POSTERIOR UPPER
Published
2017-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ELMDenture, Plastic, Teeth

Product Code Classifications

CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Premarket Submissions

SubmissionSupplement
K992854000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K992854000ARTIFICIAL TEETH (ACRYLIC TEETH)Masterdent Ltda.2000-02-07ELM

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D873DAPOSUPP1PrimaryHIBCC0

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Storage this product in a cool and dry area

Sterilization Methods

Method

Contacts

PhoneEmail
(574)4489345sales@masterdent.com.co

Regulatory Flags

DUNS number
880330126
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D873ANPOSUPP32MA35651STARTONEPOSTERIOR UPPER2021-06-25
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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

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