FDA.reportPublic FDA data

3Delta Tray Rose

Primary DI
EDEL16216200
Brand
3Delta Tray Rose
Company
DeltaMed GmbH
Model
1621620
Catalog number
1621620
Device description
3Delta Tray Rose 1000g
Published
2025-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDEL16216200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00avoid direct sunlight
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344805101
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDEL6051070Insure® Lite6051076051072023-06-12
EDEL6021080Insure® 6021086021082023-06-05
04260635980481RS Surgical GuideRS001533RS0015332022-02-11
04260635980542RS Try-InRS001535RS0015352022-02-11
04260635981556PRO Resins Guide X019.3054019.30542026-01-26
EDEL6021010Insure® 6021016021012023-06-05
EDEL6021050Insure® 6021056021052023-06-05
04260635981570RS VIVO GuideRS006196RS0061962025-11-24
EDEL160526003Delta Guide XT160526016052602025-11-24
EDEL6051010Insure® Lite6051016051012023-06-05
EDEL6051020Insure® Lite6051026051022023-06-12
EDEL605ACL0Insure® Lite Automix605ACL605ACL2023-06-12
EDEL6021020Insure® 6021026021022023-06-05
EDEL160511003Delta Splint160511016051102022-02-11
EDEL160524003Delta Guide S160524016052402022-02-11
EDEL162112003Delta Try-In162112016211202022-01-31
04260635981587RS VIVO TrayRS006198RS0061982025-07-29
04260635981594RS VIVO Try-InRS006199RS0061992025-07-29
EDEL162112103Delta Try-In XT162112116211212025-07-29
04260635981600RS VIVO C&B UltimateRS006202RS0062022025-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975527188057MOLEKURShanghai Coherz Technology Co., Ltd.EBH2026-06-04
06975527188408MOLEKURShanghai Coherz Technology Co., Ltd.EBH2026-06-04
D080XXTRR05KGXXW050TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRR05KGXXXA10TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRR05KGXXXA20TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXW050TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXXA10TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXXA20TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRT05KGXXBLU0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRT05KGXXPNK0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRTX1KGXXBLU0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRTX1KGXXPNK0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
00197998216121Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216138Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216152Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216169Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216176Clarity™Solventum Orthodontics CorporationEBH2026-04-25
09359215000376DentaTRAY OrangeASIGA PTY LTDEBH2025-01-17
08800017902043Disposable Impression Bite TrayDXM CO., LTDEBH2024-06-11
08800017902074Disposable Impression Bite TrayDXM CO., LTDEBH2024-06-11
D248628000Surfactant 32ozHAGER WORLDWIDE, INC.EBH2023-07-13
D248628011Surfactant 8ozHAGER WORLDWIDE, INC.EBH2023-07-13
20386040012710COE®Gc America Inc.EBH2023-04-20
20386040012727COE®Gc America Inc.EBH2023-04-20
20386040012734COE®Gc America Inc.EBH2023-04-20
20386040012741COE®Gc America Inc.EBH2023-04-20
20386040012758COE®Gc America Inc.EBH2023-04-20
20386040012765COE®Gc America Inc.EBH2023-04-20
20386040012772COE®Gc America Inc.EBH2023-04-20
20386040012789COE®Gc America Inc.EBH2023-04-20