High-speed Turbine Handpieces for Single Use

Primary DI
06970278690446
Brand
High-speed Turbine Handpieces for Single Use
Company
Beijing Dongbo Dental Handpiece Co.,Ltd.
Model
TBY03-BZ
Published
2020-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
06970278690446PackageGS110In Commercial Distribution
06970278690323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970278690446069702786904466970278690446
06970278690323069702786903236970278690323

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
DM exempt
false
Premarket exempt
false
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 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
06970278690453High-speed Turbine Handpieces for Single UseTBY03-BZG2020-03-06
06970278690460High-speed Turbine Handpieces for Single UseTBY03-XZJG2020-03-06

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07640397422035Statmatic sprayDent4You AGEFB2026-04-24
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J0071600436001USA1PM 1:2Bien-Air Dental SAEFB2025-10-13
J0071600052001USA1PM 1:1 EXT SPRAYBien-Air Dental SAEFB2025-10-10
J0071600692001USA1CA 20:1 L MICRO-SERIESBien-Air Dental SAEFB2025-10-10
J0071601136001USA1CA NOVA 1:1L MSBien-Air Dental SAEFB2025-10-10
J0071601138001USA1CA NOVA 1:5L MSBien-Air Dental SAEFB2025-10-10
J021300850001WG-67 AW & H Dentalwerk Bürmoos GmbHEFB2025-03-04
J021300740001TE-95 BC TurbineW & H Dentalwerk Bürmoos GmbHEFB2024-07-29
J021112330111OS30W & H Dentalwerk Bürmoos GmbHEFB2024-07-03
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J021301090001AM-20 E BCW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301110001AM-25 E BC AirmotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
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