3Delta Denture Fix 1606910

GUDID EDEL16069100

3Delta Denture Fix 8g

DeltaMed GmbH

Dental prosthesis-component adhesive
Primary Device IDEDEL16069100
NIH Device Record Key5c545a91-a919-43ec-97bd-eee47304d9e8
Commercial Distribution StatusIn Commercial Distribution
Brand Name3Delta Denture Fix
Version Model Number1606910
Catalog Number1606910
Company DUNS344805101
Company NameDeltaMed GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight
Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *avoid direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDEL16069100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-21
Device Publish Date2022-02-11

Devices Manufactured by DeltaMed GmbH

EDEL16131100 - 3Delta UNlimited2025-03-24 3Delta UNlimited A1 500g
EDEL16131200 - 3Delta UNlimited2025-03-24 3Delta UNlimited A2 500g
EDEL16131300 - 3Delta UNlimited2025-03-24 3Delta UNlimited A3 500g
EDEL16131350 - 3Delta UNlimited2025-03-24 3Delta UNlimited A3.5 500g
EDEL16131500 - 3Delta UNlimited2025-03-24 3Delta UNlimited Bleach 500g
EDEL16131550 - 3Delta UNlimited2025-03-24 3Delta UNlimited B1 500g
EDEL16131600 - 3Delta UNlimited2025-03-24 3Delta UNlimited C1 500g
EDEL16132100 - 3Delta UNlimited2025-03-24 3Delta UNlimited A1 1000g

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.