FDA.reportPublic FDA data

UniCore

Primary DI
00883205020413
Brand
UniCore
Company
ULTRADENT PRODUCTS, INC.
Model
7124
Catalog number
7124
Device description
UniCore Drill Size #4 Refill
Published
2018-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883205034366Direct MarkingGS10
00883205020413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883205034366008832050343668832050343660883205034366
00883205020413008832050204138832050204130883205020413

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)572-4200customerservice@ultradent.com

Regulatory Flags#

DUNS number
013369913
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00883205042835Opalustre5545542026-03-10
00883205044068Enamelast690669062026-02-11
00883205044075Enamelast690769072026-02-11
00883205044082Enamelast691369132026-02-11
00883205044099Enamelast690869082026-02-11
00883205044105Enamelast690969092026-02-11
00883205044112Enamelast691069102026-02-11
00883205044129Enamelast691169112026-02-11
00883205044136Enamelast691269122026-02-11
00883205044983Porcelain Repair110811082026-01-30
00883205044372Valo X6496-DU6496-DU2025-12-04
00883205044389Valo X6497-DU6497-DU2025-12-04
00883205044396Valo X6498-DU6498-DU2025-12-04
00883205044402Valo X6499-DU6499-DU2025-12-04
00883205044419Valo X6519-DU6519-DU2025-12-04
00883205044426Valo X6538-DU6538-DU2025-12-04
00883205044143Enamelast689568952025-11-14
00883205044150Enamelast689668962025-11-14
00883205044167Enamelast689768972025-11-14
00883205044174Enamelast689868982025-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7717248LTF1Dental CityICP, INC.EJL2026-05-26
D7717270021Dental CityICP, INC.EJL2026-05-26
D7717270031Dental CityICP, INC.EJL2026-05-26
D7717270041Dental CityICP, INC.EJL2026-05-26
D7717270061Dental CityICP, INC.EJL2026-05-26
D7717270081Dental CityICP, INC.EJL2026-05-26
D7717270091Dental CityICP, INC.EJL2026-05-26
D7717271041Dental CityICP, INC.EJL2026-05-26
D7717271061Dental CityICP, INC.EJL2026-05-26
D7717271081Dental CityICP, INC.EJL2026-05-26
D7717271141Dental CityICP, INC.EJL2026-05-26
D7717272041Dental CityICP, INC.EJL2026-05-26
D7717272051Dental CityICP, INC.EJL2026-05-26
D7717272061Dental CityICP, INC.EJL2026-05-26
D7717272141Dental CityICP, INC.EJL2026-05-26
D7717272741Dental CityICP, INC.EJL2026-05-26
D7717273031Dental CityICP, INC.EJL2026-05-26
D7717273041Dental CityICP, INC.EJL2026-05-26
D7717273771Dental CityICP, INC.EJL2026-05-26
D7717273781Dental CityICP, INC.EJL2026-05-26
D7717273791Dental CityICP, INC.EJL2026-05-26
D7717274041Dental CityICP, INC.EJL2026-05-26
D7717274061Dental CityICP, INC.EJL2026-05-26
D7717274081Dental CityICP, INC.EJL2026-05-26
D7717275721Dental CityICP, INC.EJL2026-05-26
D7717275831Dental CityICP, INC.EJL2026-05-26
D7717276131Dental CityICP, INC.EJL2026-05-26
D7717276421Dental CityICP, INC.EJL2026-05-26
D7717276641Dental CityICP, INC.EJL2026-05-26
D7717276761Dental CityICP, INC.EJL2026-05-26