FDA.report

House Brand Dentistry

Primary DI
00810132802249
Brand
House Brand Dentistry
Company
House Brand Dentistry
Model
HSB-300107
Device description
HSB - Bone File 21 (Miller)
Published
2024-01-29
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
false

Related Records

Product Codes

CodeName
DZNInstruments, Dental Hand

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810132802249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810132802249008101328022498101328022490810132802249

GMDN Terms

TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
203768304
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
true
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 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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06438311708782LMDentalLM-DentalDZN2026-05-25
06438311708799LMDentalLM-DentalDZN2026-05-25
06438311708805LMDentalLM-DentalDZN2026-05-25
06438311708676LMDentalLM-DentalDZN2026-03-23
06438311708683LMDentalLM-DentalDZN2026-03-23
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06438311708706LMDentalLM-DentalDZN2026-03-23
06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
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