FDA.report

House Brand Dentistry

Primary DI
10810189431307
Brand
House Brand Dentistry
Company
Frontier Dental Supply Inc
Model
HSB-401857
Device description
HSB - Round End Taper Diamonds 850-014M 10/Pk
Published
2025-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810189431300PrimaryGS10
10810189431307Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810189431300008101894313008101894313000810189431300
1081018943130710810189431307

GMDN Terms

TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method
Dry Heat Sterilization

Regulatory Flags

DUNS number
203768304
Device count
10
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
true
Expiration date on label
true
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 DIBrandModelCatalogPublished
10810132809986House Brand DentistryHSB-1005612026-02-13
00810132808135House Brand DentistryHSB-1091202026-02-10
10810132809443House Brand DentistryHSB-4113012026-02-10
10810189432458House Brand DentistryHSB-1005742025-09-02
00810132809958House Brand DentistryHSB-1005602025-08-29
10810132809948House Brand DentistryHSB-1005702025-08-29
10810189432427House Brand DentistryHSB-1005712025-08-29
10810189432434House Brand DentistryHSB-1005722025-08-29
00810132802133House Brand DentistryHSB-1005332025-08-06
00810132808067House Brand DentistryHSB-1002352025-08-05
10810132808200House Brand DentistryHSB-1002222025-08-05
10810132808552House Brand DentistryHSB-4111262025-07-07
10810132808576House Brand DentistryHSB-4111312025-07-07
10810132808590House Brad DentistryHSB-4111332025-07-07
10810132808613House Brand DentistryHSB-4111352025-07-07
10810132808644House Brand DentistryHSB-4111382025-07-07
10810132808682House Brand DentistryHSB-4111422025-07-07
10810132808699House Brand DentistryHSB-4111512025-07-07
10810132808705House Brand DentistryHSB-4111522025-07-07
00810132809934House Brand DentistryHSB-1005402025-07-07

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