Joy-3D Dental

GUDID 00817169020455

JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm A1

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Dental composite resin
Primary Device ID00817169020455
NIH Device Record Key3390b4b8-d67d-4ae1-aa3f-318012a0d623
Commercial Distribution StatusIn Commercial Distribution
Brand NameJoy-3D Dental
Version Model NumberJFN-CA1
Company DUNS080194935
Company Name3D DENTAL DESIGNS AND DEVELOPMENT, LLC
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 Usefalse
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 38 Degrees Fahrenheit and 76 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100817169020455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-27
Device Publish Date2016-12-14

On-Brand Devices [Joy-3D Dental]

00817169021360JOY-ALLOY 3 SPILL REGULAR SET JAR/50
00817169021353JOY-ALLOY 2 SPILL REGULAR SET JAR/50
00817169021346JOY-ALLOY 1 SPILL REGULAR SET JAR/50
00817169021339JOY-ALLOY 3 SPILL FAST SET JAR/50
00817169021322JOY-ALLOY 2 SPILL FAST SET JAR/50
00817169021315JOY-ALLOY 1 SPILL FAST SET JAR/50
00817169020455JOYFIL Nano-Hybrid Composite Refill Compules 20 x .25gm A1

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