FDA.report

3Delta Denture Teeth

Primary DI
EDEL16120100
Brand
3Delta Denture Teeth
Company
DeltaMed GmbH
Model
1612010
Catalog number
1612010
Device description
3Delta Denture Teeth A1 1000g
Published
2022-09-23
Public version status
New
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
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications

CodeDeviceSpecialtyClass
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EDEL16120100PrimaryHIBCC0

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, Specify00avoid direct sunlight
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
344805101
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04260635981556PRO Resins Guide X019.3054019.30542026-01-26
04260635981570RS VIVO GuideRS006196RS0061962025-11-24
EDEL160526003Delta Guide XT160526016052602025-11-24
04260635981587RS VIVO TrayRS006198RS0061982025-07-29
04260635981594RS VIVO Try-InRS006199RS0061992025-07-29
EDEL162112103Delta Try-In XT162112116211212025-07-29
EDEL162162003Delta Tray Rose162162016216202025-07-29
04260635981600RS VIVO C&B UltimateRS006202RS0062022025-06-25
04260635981617RS VIVO C&B UltimateRS006203RS0062032025-06-25
04260635981624RS VIVO C&B UltimateRS006204RS0062042025-06-25
04260635981631RS VIVO C&B UltimateRS006206RS0062062025-06-25
04260635981648RS VIVO C&B UltimateRS006205RS0062052025-06-25
EDEL161311003Delta UNlimited161311016131102025-03-14
EDEL161312003Delta UNlimited161312016131202025-03-14
EDEL161313003Delta UNlimited161313016131302025-03-14
EDEL161313503Delta UNlimited161313516131352025-03-14
EDEL161315003Delta UNlimited161315016131502025-03-14
EDEL161315503Delta UNlimited161315516131552025-03-14
EDEL161316003Delta UNlimited161316016131602025-03-14
EDEL161321003Delta UNlimited161321016132102025-03-14

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