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
D950133802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950133952360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134802360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134812360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134822360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134832360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134842360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134852360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134902360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134912360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134922360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134932360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134942360Xtreme PowerLARES RESEARCHEFB2026-09-04
D950134952360Xtreme PowerLARES RESEARCHEFB2026-09-04
00366975072108SterlingBENCO DENTAL SUPPLY CO.EGS2026-08-27
00366975072115SterlingBENCO DENTAL SUPPLY CO.EGS2026-08-27
J0071602490011HOSE MX2 400 GREY_102646BIEN-AIR PORTUGAL, UNIPESSOAL, LDAEFB2026-08-27
07613353240011AIR-FLOWE.M.S. Electro Medical Systems S.A.EFB2026-07-21
07613353046897AIR-FLOW® PERIO handy 3.0 PERIO handpieceE.M.S. Electro Medical Systems S.A.EFB2026-07-14
07613353239992AIR-FLOW Handpiece 120°E.M.S. Electro Medical Systems S.A.EFB2026-07-14