SonicFill 3 36712

GUDID 00841396185274

Sonic-Activated, Single-Fill Composite; Unidose Refill; A2

Kerr Corporation

Dental composite resin
Primary Device ID00841396185274
NIH Device Record Key3c901acb-e421-414e-8204-d5121163e31b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonicFill 3
Version Model Number36712
Catalog Number36712
Company DUNS199354556
Company NameKerr Corporation
Device Count20
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

Customer Support Contacts

Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx
Phone8005377123
Emailxxx@xxx.xxx

Device Dimensions

Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram
Weight5 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841396185274 [Primary]
GS100841396194979 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBCSealant, Pit And Fissure, And Conditioner

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-20
Device Publish Date2018-07-18

On-Brand Devices [SonicFill 3]

00841396185304Sonic-Activated, Single-Fill Composite; Intro Kit
008413961852987/22/2018
00841396185281Sonic-Activated, Single-Fill Composite; Unidose Refill; A3
00841396185274Sonic-Activated, Single-Fill Composite; Unidose Refill; A2
00841396185267Sonic-Activated, Single-Fill Composite; Unidose Refill; A1

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