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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

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