FDA.reportPublic FDA data

High-speed Turbine Handpieces for Single Use

Primary DI
06970278690071
Brand
High-speed Turbine Handpieces for Single Use
Company
Beijing Dongbo Dental Handpiece Co.,Ltd.
Model
TBY03-DKJW
Published
2018-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172543000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172543000High-speed Turbine Handpieces for Single UseBeijing Dongbo Dental Handpiece Co., Ltd.2018-07-11EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970278690224PackageGS110In Commercial Distribution
06970278690071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970278690224069702786902246970278690224
06970278690071069702786900716970278690071

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, pneumaticA hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544504276
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970278690255High-speed Turbine Handpieces for Single UseTBY04-DZJG2020-03-06
06970278690262High-speed Turbine Handpieces for Single UseTBY03-DZ2020-03-06
06970278690279High-speed Turbine Handpieces for Single UseTBY03-DZG2020-03-06
06970278690286High-speed Turbine Handpieces for Single UseTBY03-DZJQW2020-03-06
06970278690309High-speed Turbine Handpieces for Single UseTBY03-DZJQ2020-03-06
06970278690316High-speed Turbine Handpieces for Single UseTBY03-DKJQ2020-03-06
06970278690323High-speed Turbine Handpieces for Single UseTBY03-BZ2020-03-06
06970278690330High-speed Turbine Handpieces for Single UseTBY03-BZG2020-03-06
06970278690347High-speed Turbine Handpieces for Single UseTBY03-XZJG2020-03-06
06970278690354High-speed Turbine Handpieces for Single UseTBY03-XKJ2020-03-06
06970278690361High-speed Turbine Handpieces for Single UseTBY03-XZJ2020-03-06
06970278690378High-speed Turbine Handpieces for Single UseTBY04-DZJG2020-03-06
06970278690385High-speed Turbine Handpieces for Single UseTBY03-DZ2020-03-06
06970278690392High-speed Turbine Handpieces for Single UseTBY03-DZG2020-03-06
06970278690408High-speed Turbine Handpieces for Single UseTBY03-DZJQW2020-03-06
06970278690293High-speed Turbine Handpieces for Single UseTBY03-DKJQW2020-03-06
06970278690422High-speed Turbine Handpieces for Single UseTBY03-DZJQ2020-03-06
06970278690439High-speed Turbine Handpieces for Single UseTBY03-DKJQ2020-03-06
06970278690446High-speed Turbine Handpieces for Single UseTBY03-BZ2020-03-06
06970278690453High-speed Turbine Handpieces for Single UseTBY03-BZG2020-03-06

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