FDA.reportPublic FDA data

Burkhart Dental Supply

Primary DI
00810052610320
Brand
Burkhart Dental Supply
Company
BURKHART DENTAL SUPPLY CO., THE
Model
72721842
Device description
Premium Bite Registration HP Fast Set 50ml (2 pack)
Published
2024-01-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810052610320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810052610320008100526103208100526103200810052610320

GMDN Terms#

Term, Definition table
TermDefinition
Polyether dental impression materialAn elastomeric, polyether-based material capable of reacting to form a rubber-like substance used to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight50Milligram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius25 Degrees Celsius
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
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
00854212006028"Burkhart 3-0 Plain Gut Suture 18"", C-6 Needle"727207512016-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081666Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082601Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082991AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083042AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083080AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083134AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083141AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083196AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083202AlginkidMAJOR PRODOTTI DENTARI SPAELW2026-10-20