FDA.reportPublic FDA data

SM3

Primary DI
08800000995274
Brand
SM3
Company
Osstem Implant Co., Ltd._Gasan Branch
Model
S200EL
Device description
S200EL Contra angle only - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.
Published
2019-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KMWHandpiece, Rotary Bone Cutting

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMWHandpiece, Rotary Bone CuttingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800000995274Direct MarkingGS10
08800000995229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800000995274088000009952748800000995274
08800000995229088000009952298800000995229

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, line-poweredA hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
689515024
Device count
1
DM exempt
false
Premarket exempt
false
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800000995229SM3S200EL2019-04-25
08800000995212SM3SM3 120V OPT2019-04-25
08800000995236SM3SL2019-04-25
08800000995014OsstemEXARO2016-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126043153SM7 US ( Complete Set )HIOSSEN, INC.KMW2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceHIOSSEN, INC.KMW2026-01-09
04589551388813SG20MNAKANISHI INC.KMW2025-08-28
04589551388820X-SG20MLNAKANISHI INC.KMW2025-08-28
04560264576940SG20MNAKANISHI INC.KMW2025-08-28
04560264576957X-SG20MLNAKANISHI INC.KMW2025-08-28
J021101008011S-8 RW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008021S-8 OW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008031S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008010S-8 RW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008020S-8 OW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021101008030S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
06974267891104COXOFoshan COXO Medical Instrument Co.,Ltd.KMW2024-07-04
06974267891067COXOFoshan COXO Medical Instrument Co.,Ltd.KMW2024-03-30
J021300320021WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11
J021300320020WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11
04589551382446X-SG93LNAKANISHI INC.KMW2022-02-17
04589551382453X-SG93NAKANISHI INC.KMW2022-02-17
04589551382460X-SG25LNAKANISHI INC.KMW2022-02-17
04560264557109X-SG93LNAKANISHI INC.KMW2022-02-17
04560264557116X-SG93NAKANISHI INC.KMW2022-02-17
04560264557130X-SG25LNAKANISHI INC.KMW2022-02-17
D762KITBOPR000Implant-OneImplant Logistics, Inc.KMW2021-05-12
D762KITBOPR001Implant-OneImplant Logistics, Inc.KMW2021-05-12
00840117305151Plastic Overbed Table, H Base, Silver Vein, GreyDynarex CorporationKMW2021-04-22
00840117305168Plastic Overbed Table, H Base, Silver Vein, CherryDynarex CorporationKMW2021-04-22
00840117305182Plastic Overbed Table, H Base, Silver Vein, Mahogany Dynarex CorporationKMW2021-04-22
00814913029603SM3HIOSSEN, INC.KMW2021-01-20
J021304110001S-16 Surgical Handpiece 1:2W & H Dentalwerk Bürmoos GmbHKMW2020-09-15
J02130095000Zygoma SZ-75W & H Dentalwerk Bürmoos GmbHKMW2020-07-30