FDA.reportPublic FDA data

Bondent

Primary DI
06942135219107
Brand
Bondent
Company
United Dental Changzhou
Model
V1
Published
2025-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942135219107PrimaryGS10
86942135219103Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942135219107069421352191076942135219107
8694213521910386942135219103

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, reusableA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
543963705
Device count
5
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942135218902BondentV12025-05-06
06942135218919BondentV12025-05-06
06942135218926BondentV12025-05-06
06942135218933BondentV12025-05-06
06942135218940BondentV12025-05-06
06942135218957BondentV12025-05-06
06942135218964BondentV12025-05-06
06942135218971BondentV12025-05-06
06942135218988BondentV12025-05-06
06942135218995BondentV12025-05-06
06942135219008BondentV12025-05-06
06942135219015BondentV12025-05-06
06942135219022BondentV12025-05-06
06942135219039BondentV12025-05-06
06942135219046BondentV12025-05-06
06942135219053BondentV12025-05-06
06942135219060BondentV12025-05-06
06942135219077BondentV12025-05-06
06942135219084BondentV12025-05-06
06942135219091BondentV12025-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00887919581741DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
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08800394921293Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921309Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08800394921323Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08800394921347Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921354Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921361Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08800394921385Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921392Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921408Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921415Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921422Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921439Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921446Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921453Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921460Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921477Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08059224218007INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
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06942686761230DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761247DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761254DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21