FDA.reportPublic FDA data

AG Neovo

Primary DI
04710739590067
Brand
AG Neovo
Company
ASSOCIATED INDUSTRIES CHINA, INC.
Model
REVOLUTION R-6500M4
Device description
Dental High-speed Handpiece and Accessories
Published
2020-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04710739590067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04710739590067047107395900674710739590067

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
656068681
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04710739590197AG NeovoREVOLUTION R-55102021-12-17
04710739590203AG NeovoREVOLUTION R-55002021-12-17
04710739590210AG NeovoREVOLUTION R-40102021-12-17
04710739590227AG NeovoREVOLUTION R-40002021-12-17
04710739590234AG NeovoREVOLUTION R-40052021-12-17
04710739590241AG NeovoREVOLUTION R-20102021-12-17
04710739590258AG NeovoREVOLUTION R-20002021-12-17
04710739590265AG NeovoREVOLUTION R-20052021-12-17
04710739590272AG NeovoREVOLUTION R-11052021-12-17
04710739590289AG NeovoREVOLUTION R-11042021-12-17
04710739590180AG NeovoAG neovo Dental Portable Dental Equipment PDE seri2021-11-12
04710739590111AG NeovoREVOLUTION R-6800B22020-12-31
04710739590128AG NeovoREVOLUTION R-6100S2020-12-31
04710739590135AG NeovoREVOLUTION R-6110DPS2020-12-31
04710739590142AG NeovoREVOLUTION R-6510WH2020-12-31
04710739590159AG NeovoREVOLUTION R-6110WH2020-12-31
04710739590166AG NeovoREVOLUTION R-6110N2020-12-31
04710739590173AG NeovoREVOLUTION R-6100N2020-12-31
04710739590012AG NeovoLouie P-M10TR2020-06-30
04710739590029AG NeovoREVOLUTION R-6100K2020-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D7022666550StarDentalDENTALEZ, INC.EFB2026-09-18
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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
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