FDA.reportPublic FDA data

Dental Instrument

Primary DI
08800016176759
Brand
Dental Instrument
Company
Cowellmedi Co.,Ltd
Model
KFR01L
Published
2026-01-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LRZScrewdriver, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRZScrewdriver, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800016176759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800016176759088000161767598800016176759

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. 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
00841731137951TITANEX VILEX LLCLRZ2026-05-15
00841731137968TITANEX VILEX LLCLRZ2026-05-15
00841731138149TITANEX VILEX LLCLRZ2026-05-15
00841731140784TITANEX VILEX LLCLRZ2026-05-15
00841731141927TITANEX VILEX LLCLRZ2026-05-15
00841731146816TITANEX VILEX LLCLRZ2026-05-15
00841731146823TITANEX VILEX LLCLRZ2026-05-15
00841731146830TITANEX VILEX LLCLRZ2026-05-15
00841731146847TITANEX VILEX LLCLRZ2026-05-15
00841731152237DYNEX VILEX LLCLRZ2026-05-15
00841731152121DYNEX VILEX LLCLRZ2026-05-11
00841731152183DYNEX VILEX LLCLRZ2026-05-11
00841731152282DYNEX VILEX LLCLRZ2026-05-11
08800016101362Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114447Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114454Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114461Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114478Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016114485Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115024Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115840Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016115857Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016116014Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016144772Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016163087Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016163094Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176742Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176766Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176773Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28
08800016176780Dental InstrumentCowellmedi Co.,LtdLRZ2026-01-28