FDA.reportPublic FDA data

MAXSO

Primary DI
00990010301795
Brand
MAXSO
Company
Beyes Dental Canada Inc
Model
SL1002
Catalog number
EP12-NS
Device description
EP12-NS,Hygiene Handpiece for DPA (Disposable Prophy Angle), 4:1
Published
2023-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00990010301795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00990010301795009900103017959900103017950990010301795

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool handpiece motorless componentA component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
244261462
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
00990010301290DURAYDC1001DC12023-05-11
00837699000109DURAYDC10012022-10-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640397422028Statcare sprayDent4You AGEFB2026-04-24
07640397422035Statmatic sprayDent4You AGEFB2026-04-24
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
J021301130001AM-20 BC Air MotorW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301240011WE-56 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301250011WE-57 T MWW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301260011HE-43 T MW Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301270011WE-56 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301280011WE-57 T SD Alegra Contra-angle HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11
J021301290011HE-43 T SD Alegra HandpieceW & H Dentalwerk Bürmoos GmbHEFB2023-07-11