FDA.reportPublic FDA data

Dental Implants Accesseories-Reusable

Primary DI
08800016108767
Brand
Dental Implants Accesseories-Reusable
Company
Cowellmedi Co.,Ltd
Model
2STH001SL
Published
2025-10-14
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800016108767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800016108767088000161087678800016108767

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, reusableA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a reusable device.

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800016104134INNO SLA Sub. Pre-Mount Fixture2SMHR001S2025-10-20
08800016104141INNO SLA Sub. Pre-Mount Fixture2SMHR001B2025-10-20
08809471724758INNO Submerged Implant System-Replica2SRHR0012018-05-24
08800016100686Dental Implants Accesseories-Single Use2SMPC452026-08-03
08800016108774Dental Implants Accesseories-Reusable2SMGP0122026-07-28
08800016111057Dental Implants Accesseories-Reusable2SMGP0122025-10-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701045246398KONTACTBIOTECH DENTALNDP2026-10-26
03701045279471KONTACTBIOTECH DENTALNDP2026-10-26
03701045279488KONTACTBIOTECH DENTALNDP2026-10-26
03701045279495KONTACTBIOTECH DENTALNDP2026-10-26
03701045279501KONTACTBIOTECH DENTALNDP2026-10-26
03701045279518KONTACTBIOTECH DENTALNDP2026-10-26
03701045279525KONTACTBIOTECH DENTALNDP2026-10-26
03701045279532KONTACTBIOTECH DENTALNDP2026-10-26
03701045279549KONTACTBIOTECH DENTALNDP2026-10-26
03701045279556KONTACTBIOTECH DENTALNDP2026-10-26
03701045279563KONTACTBIOTECH DENTALNDP2026-10-26
03701045279570KONTACTBIOTECH DENTALNDP2026-10-26
03701045279587KONTACTBIOTECH DENTALNDP2026-10-26
03701045279594KONTACTBIOTECH DENTALNDP2026-10-26
03701045279600KONTACTBIOTECH DENTALNDP2026-10-26
03701045279617KONTACTBIOTECH DENTALNDP2026-10-26
03701045279624KONTACTBIOTECH DENTALNDP2026-10-26
03701045279631KONTACTBIOTECH DENTALNDP2026-10-26
03701045279648KONTACTBIOTECH DENTALNDP2026-10-26
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05397311032826Straight DriverHADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
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05397311032895Driver BioHorizons 4.5HADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26
05397311032901Driver BioHorizons 5.7HADER SOLUTIONS & DISTRIBUTION LIMITEDNDP2026-10-26