FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040110867
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5701448
Catalog number
5701448
Device description
Maxima-iL Implant HP F/O
Published
2019-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKYHandpiece, water-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKYHandpiece, Water-PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040110867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040110867003040401108673040401108670304040110867

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system instrument unit, electricA mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809260475656Henry ScheinSaeshin Precision Co., Ltd.EKY2026-05-21
08809260475663Henry ScheinSaeshin Precision Co., Ltd.EKY2026-05-21
08809260470156TRAUSSaeshin Precision Co., Ltd.EKY2026-04-01
08809260470170TRAUSSaeshin Precision Co., Ltd.EKY2026-04-01
08809260470187TRAUSSaeshin Precision Co., Ltd.EKY2026-04-01
08809260470163TRAUS SIP10Saeshin Precision Co., Ltd.EKY2020-01-22
08809260470200X-CUBESaeshin Precision Co., Ltd.EKY2020-01-22
08809260470705TRAUS SIP10Saeshin Precision Co., Ltd.EKY2020-01-22
08809260470712TRAUS SIP10Saeshin Precision Co., Ltd.EKY2020-01-22
08809260470729TRAUS SIP10Saeshin Precision Co., Ltd.EKY2020-01-22
08809260470736TRAUS SIP10Saeshin Precision Co., Ltd.EKY2020-01-22
00304040110850Henry ScheinHENRY SCHEIN, INC.EKY2019-06-05