FDA.report

SGS-E

Primary DI
04560224972829
Brand
SGS-E
Company
NAKANISHI INC.
Model
SGS-E
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KMWHANDPIECE, ROTARY BONE CUTTING

Product Code Classifications

CodeDeviceSpecialtyClass
KMWHandpiece, Rotary Bone CuttingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560224972829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04560224972829045602249728294560224972829

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
690710546
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

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Other Devices Sharing Product Codes

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04560264576940SG20MNAKANISHI INC.KMW2025-08-28
04560264576957X-SG20MLNAKANISHI INC.KMW2025-08-28
J021101008010S-8 RW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
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J021101008030S-8 SW & H Dentalwerk Bürmoos GmbHKMW2025-08-26
J021300320020WS-75 LG surgical handpiece, 20:1, MISW & H Dentalwerk Bürmoos GmbHKMW2023-07-11
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
J021304110001S-16 Surgical Handpiece 1:2W & H Dentalwerk Bürmoos GmbHKMW2020-09-15
J02130095000Zygoma SZ-75W & H Dentalwerk Bürmoos GmbHKMW2020-07-30
00845694094290OsteoMedOSTEOMED LLCKMW2020-04-28
00842528123706OsteoMedOSTEOMED LLCKMW2019-11-08
08800000995212SM3Osstem Implant Co., Ltd._Gasan BranchKMW2019-04-25
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00842528114551OsteoMedOSTEOMED LLCKMW2018-10-26
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