FDA.reportPublic FDA data

wenjian

Primary DI
06972249850378
Brand
wenjian
Company
Foshan Wenjian Medical Instrument Co., Ltd.
Model
WJ-424
Published
2021-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EFBHandpiece, Air-Powered, Dental
EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181691000High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd.2020-05-26EFB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972249850375PackageGS1120In Commercial Distribution
06972249850378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697224985037516972249850375
06972249850378069722498503786972249850378

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
543064035
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972249850217wenjianWJ-1142021-03-26
06972249850224wenjianWJ-1122021-03-26
06972249850231wenjianWJ-1242021-03-26
06972249850248wenjianWJ-1222021-03-26
06972249850255wenjianWJ-1342021-03-26
06972249850262wenjianWJ-1322021-03-26
06972249850279wenjianWJ-1442021-03-26
06972249850286wenjianWJ-1422021-03-26
06972249850293wenjianWJ-1542021-03-26
06972249850309wenjianWJ-1522021-03-26
06972249850316wenjianWJ-1642021-03-26
06972249850323wenjianWJ-1622021-03-26
06972249850330wenjianWJ-4142021-03-26
06972249850361wenjianWJ-4122021-03-26
06972249850385wenjianWJ-4222021-03-26
16972249850214wenjianWJ-1142021-03-26
16972249850221wenjianWJ-1122021-03-26
16972249850238wenjianWJ-1242021-03-26
16972249850245wenjianWJ-1222021-03-26
16972249850252wenjianWJ-1342021-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810021439778DCI EdgeDCI International, LLCEFB2026-06-01
00810021439785DCI EdgeDCI International, LLCEFB2026-06-01
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
07640397422028Statcare sprayDent4You AGEFB2026-04-24
07640397422035Statmatic sprayDent4You AGEFB2026-04-24
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
J021020835001MCA-RM-BCW & H Dentalwerk Bürmoos GmbHEFB2025-12-02
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
J00715031850011NGO motor driverBien-Air Dental SAEFB2023-09-15
J021026904001MCA-RM-RQW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021026930001MCA-ISO-CKW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021031035001MCA-ISO-MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021052046001MCA-ISO-PLW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021060371001Universal Adapter VDWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021111443001RC-43 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021112458001RC-58 Contra-Angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301040001AM-25 A BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301090001AM-20 E BCW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301110001AM-25 E BC AirmotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301120001AM-25 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11