FDA.reportPublic FDA data

Dental Instrument

Primary DI
08800016113983
Brand
Dental Instrument
Company
Cowellmedi Co.,Ltd
Model
KAE01
Published
2024-08-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMJElevator, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800016113983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800016113983088000161139838800016113983

GMDN Terms#

Term, Definition table
TermDefinition
Dental elevator, tooth/rootA hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688753763
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800016115994Screw KitKIGICS0012026-03-20
08800016163070Dental InstrumentSSFSS100N2026-01-29
08800016176841Dental InstrumentKSRIG25R2026-01-29
08800016176858Dental InstrumentKSRIG21N2026-01-29
08800016176865Dental InstrumentKTW0032026-01-29
08800016101362Dental InstrumentKRMSD10S2026-01-28
08800016114256Dental Implants Accesseories-Single UseSSB100SN2026-01-28
08800016114447Dental InstrumentKMTD18S2026-01-28
08800016114454Dental InstrumentKMTD18L2026-01-28
08800016114461Dental InstrumentKHTD18082026-01-28
08800016114478Dental InstrumentKHTD18202026-01-28
08800016114485Dental InstrumentKHTD18152026-01-28
08800016115024Dental InstrumentKRBUD082026-01-28
08800016115840Dental InstrumentKMATD18S2026-01-28
08800016115857Dental InstrumentKMATD18L2026-01-28
08800016116014Dental InstrumentKHSPLD01S2026-01-28
08800016117769SFIT Crown GaugeSFCG2026-01-28
08800016117783Dental Implants Accesseories-Single Use2SSB100S2026-01-28
08800016144772Dental InstrumentKHSPLD01L2026-01-28
08800016146530Dental Implants Accesseories-Reusable2SMTN5552026-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7540TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7550TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7560TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7570TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7580TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7590TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7600TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7610TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7620TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7630TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7640TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7650TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7660TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7670TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7680TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7690TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7700TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7710TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7830TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7840TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7850TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149NP380810NPSACME ENTERPRISE.EMJ2026-05-01
G149NPPMH0NPSACME ENTERPRISE.EMJ2026-05-01
08961104674998Lux-PerioMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675001Lux-PerioMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675018Lux-PerioMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675025LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675032LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675049LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27
08961104675056LuxatorMELPEX BEAUTY INSTRUMENTSEMJ2026-04-27