FDA.reportPublic FDA data

Maxso M20A-NS/M4

Primary DI
00628504370414
Brand
Maxso M20A-NS/M4
Company
Beyes Dental Canada Inc
Model
MT2010
Device description
M20A-NS/M4, Air Motor, M4 Backend, Non-Spray, Non-Optic, 20K
Published
2019-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628504370414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628504370414006285043704146285043704140628504370414

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic surgical power tool system motorA compact engine that draws power from a pneumatic surgical power tool system control unit intended to convert pneumatic energy [e.g., from surgical-grade air or nitrogen (N2)] into a non-dedicated mechanical energy to perform a variety of surgical procedures that include drilling, sawing, and inserting involving bones and tough tissues. It may be available in two different forms: 1) a pistol-like handpiece that connects to a variety of surgical power tool attachments; or 2) a proximal attachment (e.g., micro-motor) to a variety of motorless handpieces. The device may be cannulated to permit use of a guidewire. It may be operated with a hand- or foot-switch. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
244261462
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00990010312418DURAY2D2025-12-15
00990010312562DURAY3D2025-12-15
00990010312579DURAYART PLUS2025-12-15
00990010312586DURAY2D CEPH2025-12-15
00990010312593DURAY3D CEPH2025-12-15
00990010312609DURAYART PLUS C2025-12-15
00990010306653Comfort-Sonic UL2214K-92024-01-19
00990010306660Comfort-Sonic UL2215K-102024-01-19
00990010306677Comfort-Sonic UL2216K-112024-01-19
00990010306684Comfort-Sonic UL2217K-602024-01-19
00990010306691Comfort-Sonic UL2218K-612024-01-19
00990010306707Comfort-Sonic UL2219K-622024-01-19
00990010306714Comfort-Sonic UL2220K-A112024-01-19
00990010306721Comfort-Sonic UL2221K-E82024-01-19
00990010306738Comfort-Sonic UL2222K-512024-01-19
00990010306462Beyes849961FG 582023-12-28
00990010306479Beyes889904FG 58L2023-12-28
00990010306486Beyes889905FG SS 5592023-12-28
00990010306493Beyes889906FG 559L2023-12-28
00990010306509Beyes850251FG SS 15582023-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20686864060943MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
20686864060950MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
00850079280069Turbo EdgeHexa DentalEGS2026-01-21
00850079280083Turbo edgeHexa DentalEGS2026-01-21
00008579280083Turbo edgeHexa DentalEGS2026-01-21
00085007928069Turbo EdgeHexa DentalEGS2026-01-21
00850079280076Turbo EdgeHexa DentalEGS2026-01-21
00850079280090Turbo EdgeHexa DentalEGS2026-01-21
00850079280106Turbo EdgeHexa DentalEGS2026-01-21
00850079280113Ergo glideHexa DentalEGS2026-01-21
08404535020892Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020922Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020953Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535020984Forza+Peter Brasseler Holdings, LLCEGS2026-01-09
08404535021738ForzaPeter Brasseler Holdings, LLCEGS2026-01-09
00304040194331Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194348Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194355Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194362Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194379Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
00304040194386Henry ScheinHENRY SCHEIN, INC.EGS2025-12-15
D745701120GLH00010Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D745701120GLH00020Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D745701120GLH00030Glidewell™Prismatik Dentalcraft, IncEGS2025-11-24
D950135030SmoothdriveLARES RESEARCHEGS2025-08-25
06971119540548Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540586Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540593Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540982Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15
06971119540999Dental HandpieceGuangdong JINME Medical Technology Co., Ltd.EGS2025-07-15