FDA.reportPublic FDA data

OSADA XL-S30

Primary DI
04580406860614
Brand
OSADA XL-S30
Company
OSADA ELECTRIC CO.,LTD.
Model
XL-S30
Catalog number
3159
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EKXHANDPIECE, DIRECT DRIVE, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580406860614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580406860614045804068606144580406860614

GMDN Terms#

Term, Definition table
TermDefinition
Line-powered dental drilling systemAn assembly of devices designed to bore and excavate bones, teeth, and tough tissues during a dental surgical procedure. It typically consists of a motorized drill handpiece and/or motor, a control unit, and a variety of attachments used to hold the drilling/excavating endpieces (e.g., drill bits, burs, polishing disks). This system is electrically-powered from the mains (e.g., 230 or 115 volt) and supplies the handpiece/motor with low-voltage electricity (e.g., 24 volt) through a control unit. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690713813
Device count
1
DM exempt
false
Premarket exempt
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04582227353498ST45ST45567312020-03-19
04580406860690ST38-90RST38-90R501162016-09-20
04580406860706ST38-90LST38-90L501172016-09-20
04580406860713ST38-90ST38-90500752016-09-20
04580406860720AP set 7AP set 7507962016-09-20
04580406860737AP point 1AP point 1460442016-09-20
04580406860744AP point 2AP point 2460452016-09-20
04580406860751AP point 3AP point 3460462016-09-20
04580406860768Diamond file A2Diamond file A2460502016-09-20
04580406860775Diamond file A3Diamond file A3460512016-09-20
04580406860782Diamond file L1Diamond file L1460472016-09-20
04582227360175ST24ST24163992016-09-20
04582227360205SC point 6SC point 6164032016-09-20
04582227360229SC point 5SC point 5164052016-09-20
04582227379610ST21BST21B500242016-09-20
04582227379849SC point 4-17SC point 4-17500762016-09-20
04582227379856SC point 4-19SC point 4-19500772016-09-20
04582227397072Plugger set#15Plugger set#15819012016-09-20
04582227397089Plugger set#20Plugger set#20819132016-09-20
04582227397096Plugger set#30Plugger set#30819252016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313230000ChecQPEGDENTIS CO. ,LTDEKX2026-03-03
10194665008444A-decA-DEC, INC.EKX2026-02-19
E27668665320Midwest IMPLANT 20:1SIRONA Dental Systems GmbHEKX2026-02-19
09010522002506SmartPeg Type 127Osstell ABEKX2026-02-09
09010522002520SmartPeg Type 137Osstell ABEKX2026-02-09
06941877827809ZarcChangzhou Sifary Medical Technology Co., Ltd.EKX2026-01-05
06944835130195NIC/SUPERLINEShenzhen Superline Technology Co., Ltd.EKX2025-12-22
10817417020395AsepticoASEPTICO, INC.EKX2025-12-16
10817417020401AsepticoASEPTICO, INC.EKX2025-12-16
08056814270117EnDrive ADVANCED TECHNOLOGY RESEARCH A.T.R. SRLEKX2025-11-26
09010522002650Osstell Beacon InstrumentOsstell ABEKX2025-09-26
09010522002667MEGA ISQ II InstrumentOsstell ABEKX2025-09-26
00860011518327InnerView® System Smart Tips Perimetrics, Inc.EKX2025-07-31
08809455602683elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08809455602720elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08809455602744elements ConnectMETA SYSTEMS CO., LTD.EKX2025-06-05
08800053084123ChecQDENTIS CO. ,LTDEKX2025-03-31
08800053092494ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092500ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092517ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092524ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092531ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092548ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092555ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092562ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092579ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092586ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
08800053092593ChecQPEG DriverDENTIS CO. ,LTDEKX2025-03-31
08800266943897ChecQPEGDENTIS CO. ,LTDEKX2025-03-31
09010522002551Osstell SmartPeg Type 112Osstell ABEKX2025-03-27