FDA.reportPublic FDA data

3Delta Splint

Primary DI
EDEL16051100
Brand
3Delta Splint
Company
DeltaMed GmbH
Model
1605110
Catalog number
1605110
Device description
3Delta Splint 1000g
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

Product Codes#

Code, Name table
CodeName
DYTMaintainer, Space Preformed, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYTMaintainer, Space Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDEL16051100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDEL6051070Insure® Lite6051076051072023-06-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906154840993e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841006e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841013e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841020e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841037e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841044e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841051e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841068e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841075e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841082e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841099e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841105e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841112e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841129e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841136e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841143e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841150e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841167e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841174e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841181e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841198e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841204e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841211e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841228e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841235e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841242e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841259e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841266e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841273e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26
08906154841280e-Space MaintainerKIDS-E-DENTAL LLPDYT2026-05-26