FDA.report

House Brand Dentistry

Primary DI
00810132801396
Brand
House Brand Dentistry
Company
House Brand Dentistry
Model
HSB-401153
Device description
HSB - Carbide Burs RA - #2 - 100/Pk
Published
2024-01-15
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
00810132801396PrimaryGS10
10810132801393Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810132801396008101328013968101328013960810132801396
1081013280139310810132801393

GMDN Terms

TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, 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

Regulatory Flags

DUNS number
203768304
Device count
100
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10810132809436House Brand DentistryHSB-4113002025-05-14
10810132809450House Brand DentistryHSB-4113022025-05-14
10810132809467House Brand DentistryHSB-4113032025-05-14
10810132809320House Brand DentistryHSB-4112082025-05-09
10810132809351House Brand DentistryHSB-4112112025-05-09
10810132809382House Brand DentistryHSB-4112142025-05-09
10810132809399House Brand DentistryHSB-4112152025-05-09
10810132808392House Brand DentistryHSB-4111082025-05-08
10810132808415House Brand DentistryHSB-4111102025-05-08
10810132808446House Brand DentistryHSB-4111132025-05-08
10810132808477House Brand DentistryHSB-4111172025-05-08
10810132808569House Brand DentistryHSB-4111282025-05-08
10810132808651House Brand DentistryHSB-4111392025-05-08
10810132808675House Brand DentistryHSB-4111412025-05-08
10810132808910House Brand DentistryHSB-4111782025-05-08
10810132808941House Brand DentistryHSB-4111782025-05-08
10810132808958House Brand DentistryHSB-4111792025-05-08
10810132809030House Brand DentistryHSB-4111502025-05-08
10810132809078House Brand DentistryHSB-4111832025-05-08
10810132809085House Brand DentistryHSB-4111842025-05-08

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