FDA.reportPublic FDA data

Henry Schein

Primary DI
08809260475663
Brand
Henry Schein
Company
Saeshin Precision Co., Ltd.
Model
Maxima Elite iL
Device description
Maxima-iL Implant HP F/O
Published
2026-05-21
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123695000TRAUS SIP10Saeshin Precision Co., Ltd.2012-12-18EKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809260475663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809260475663088092604756638809260475663

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688019566
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809260475656Henry ScheinMaxima Elite i2026-05-21
08809260475687Oral irrigation unitDB-0012026-05-21
08809260475694Oral irrigation unitDB-0052026-05-21
08809260473430TRAUSMBP20SX2026-05-20
08809260475649TRAUS SSG40SSG40 #32026-05-19
08809260472037TRAUSSC-012026-05-07
08809260472853TRAUSCSH20NN2026-05-07
08809260472860TRAUSCSH30NN2026-05-07
08809260472877TRAUSCSH11XX2026-05-07
08809260472884TRAUSTSH11XX2026-05-07
08809260472891TRAUSTC002026-05-07
08809260472907TRAUSTC102026-05-07
08809260472914TRAUSTC202026-05-07
08809260472921TRAUSTC352026-05-07
08809260471924TRAUSSP-028i2026-05-06
08809260471931TRAUSSP-024i2026-05-06
08809260471948TRAUSSP-0162026-05-06
08809260471955TRAUSSP-SAW2026-05-06
08809260471962TRAUSSP-SAW L2026-05-06
08809260471979TRAUSSP-SAW R2026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809260475656Henry 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
00304040110867Henry ScheinHENRY SCHEIN, INC.EKY2019-06-05