FDA.report

3Delta Tray

Primary DI
EDEL16213100
Brand
3Delta Tray
Company
DeltaMed GmbH
Model
1621310
Catalog number
1621310
Device description
3Delta Tray beige 500g
Published
2022-02-11
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
EBHMaterial, Impression Tray, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EDEL16213100PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental impression tray materialA material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.

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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04260635981594RS VIVO Try-InRS006199RS0061992025-07-29
EDEL162112103Delta Try-In XT162112116211212025-07-29
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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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