FDA.reportPublic FDA data

Burkhart Dental Supply

Primary DI
00810052614458
Brand
Burkhart Dental Supply
Company
BURKHART DENTAL SUPPLY CO., THE
Model
72721852
Device description
Premium Flowable Composite A3/A3.5/B3 Value Pack 3-1g Syr, 25-20G Tips
Published
2024-01-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810052614458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810052614458008100526144588100526144580810052614458

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Do not freeze. Use at room temperature.
Special Storage Condition, Specify00Keep out of sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-562-8176customerservice@burkhartdental.com

Regulatory Flags#

DUNS number
027532357
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810052610306Burkhart Dental Supply727218402024-01-15
00810052610313Burkhart Dental Supply727218412024-01-15
00810052610320Burkhart Dental Supply727218422024-01-15
00810052610337Burkhart Dental Supply727218432024-01-15
00810052610696Burkhart Dental Supply727218442024-01-15
00815878020100Burkhart Select Multivariable Sterilization Pouch 5 1/4X10 (200)727206602016-09-16
00815878020117Burkhart Select Multivariable Sterilization Pouch 2 3/4 X 9 (200)727206612016-09-16
00815878020124Burkhart Select Multivariable Sterilezation Pouch 3 1/2 x 5 1/4 (200)727206632016-09-16
00815878020131Burkhart Select Multivariable Sterilization Pouch 3-1/2 x 9 (200)727206622016-09-16
00815878021053"Burkhart Sterile Pouches 7-1/2"" x 13"" (200)"727208432018-04-13
00815878027628Burkhart Dental Supply727220272024-05-07
00815878027642Burkhart Dental Supply727220292024-05-07
00854212006165Burkhart Etching Gel 2-5ml Syringes 37.5% w/20-22ga Tips727204242016-09-16
00815878028397Burkhart Dental Supply727209812024-12-06
00815878028403Burkhart Dental Supply727209822024-12-06
00815878028410Burkhart Dental Supply727209832024-12-06
00815878028427Burkhart Dental Supply727209842024-12-06
00815878028441Burkhart Dental Supply727209862021-05-14
00854212006004"Burkhart 3-0 Chromic Gut Suture 18"", C-6 Needle"727207652016-03-03
00854212006011"Burkhart 3-0 Chromic Suture 27"", C-6 Needle"727207612016-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998226724Solventum™ Protemp™Solventum Germany GmbHEBF2026-10-08
08806383540995DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541008DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541015DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541022DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541039DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541046DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541053DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541060DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541091DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541107DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541114DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541121DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541138DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541145DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541152DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541169DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541176DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541183DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541190DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541206DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541213DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541220DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541237DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541244DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541251DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541268DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541299DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541305DIAFILDiaDent Group InternationalEBF2026-10-07
08806383541312DIAFILDiaDent Group InternationalEBF2026-10-07