Burkhart Dental Supply

GUDID 00810052618883

Core Build-Up Material Opaceous White - 25ml/48g

BURKHART DENTAL SUPPLY CO., THE

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID00810052618883
NIH Device Record Keya019eb41-9ba3-40c3-ab3d-1eb327568922
Commercial Distribution StatusIn Commercial Distribution
Brand NameBurkhart Dental Supply
Version Model Number72721963
Company DUNS027532357
Company NameBURKHART DENTAL SUPPLY CO., THE
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

Customer Support Contacts

Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com
Phone800-562-8176
Emailcustomerservice@burkhartdental.com

Device Dimensions

Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram
Weight48 Gram

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100810052618883 [Primary]

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-05
Device Publish Date2024-01-26

On-Brand Devices [Burkhart Dental Supply]

00815878025440SS MIRROR HANDLE ROUND CONE SOCKET
00815878025570Matrix System Refill Universal Tweezers
00815878025563Matrix System Refill Forceps
00815878025556Matrix System Refill Small Wedges Orange (100)
00815878025549Matrix System Refill Small Wedges Blue(100)
00815878025532Matrix System Refill Small Wedges Yellow (100)
00815878025525Matrix System Refill 6.6mm Tab Matrices (100)
00815878025518Matrix System Refill 5.5mm Tab Matrices (100)
00815878025501Matrix System Refill 4.5mm Tab Matrices (100)
00815878025495Matrix System Refill 3.5mm Tab Matrices (100)
00815878025488Matrix System Ring Refill Grey Narrow Rings (2)
00815878025471Matrix System Ring Refill Blk Standard Rings (2)
00815878025464Matrix System Starter Kit
00815878028472Varnish 5% NaF Fruity Bubblegum 0.4mL (50)
00815878020797Combo Tip High Volume Evacuator (50)
00810052610238#151 CRYER SERRATED UNIVERSAL FORCEPS
00810052610221#150 CRYER SERRATED UNIVERSAL FORCEPS
00810052610207KELLY SCI 6.25" CVD SERR ECON
00810052610191KELLY SCI 6.25" STR SERR ECON
00810052610184CROWN SCISSOR 4.5" CVD SERR ECON
00810052610177KELLY SCISSORS STRAIGHT 6.25" ECON
00810052610160KELLY SCISSORS CURVED 6.25" ECON
00810052610153SPENCER SUTURE SCISSORS 3.5" ECON
00810052610146IRIS SCISSORS STRAIGHT 4.5" ECON
00810052610139IRIS SCISSORS CURVED 4.5" ECON
00810052610122GOLDMAN-FOX SCISSORS CURVED 6.0" ECON
00810052610115DEAN GUM SCISSORS ANGLED 7.0" ECON
00810052610108CROWN & COLLAR SCISSORS CURVED 4.5" ECON
00810052610092BLUMENTHAL RONGEUR 5.5" 30° ECON
00810052610085FRIEDMAN RONGEUR 5.5" 30° ECON
00810052610078MAYO-HEAGR NEEDLE HOLDER 6" ECON
00810052610061BAUMGARTNER NEEDLE HOLDER 5.25" ECON
00810052610054CRILE-WOOD NEEDLE HOLDER 6" ECON
00810052610047CASTROVIEJO NEEDLE HOLDER 5.75" LOCKING ECON
00810052610030KELLY HEMOSTAT STRAIGHT 5.5"
00810052610023KELLY HEMOSTAT CURVED 5.5"
00810052610016HALSTEAD MOSQUITO FORCEPS STRAIGHT 4.75"
00810052610009HALSTEAD MOSQUITO FORCEPS CURVED 4.75"
00815878020681Yellow Pre-Bent Tip w/Brush End (100)
00815878020551Curved Brush Tips, Black (100)
00810052610955Disposable Mouth Mirror, White (60)
00810052610948Red Brush Tips 18GA (100)
008100526112596055-018SC Super Coarse FG Diamond (25)
00810052611242909-035SC Super Coarse FG Diamond (25)
00810052611235856-021SC Super Coarse FG Diamond (25)
00810052611228856-018SC Super Coarse FG Diamond (25)
00810052611211855-018SC Super Coarse FG Diamond (25)
00810052611204850-018SC Super Coarse FG Diamond (25)
00810052611198847-018SC Super Coarse FG Diamond (25)
00810052611181847-018C Course FG Diamond (25)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.