FDA.reportPublic FDA data

Ridge Split Chisel

Primary DI
08800209372012
Brand
Ridge Split Chisel
Company
Osstem Implant Co., Ltd.
Model
HRSO25
Published
2022-12-08
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
08800209372012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800209372012088002093720128800209372012

GMDN Terms#

Term, Definition table
TermDefinition
Dental osteotomeA hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
689051793
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800342290136OneArch Scan Body KITHOASBK2026-04-02
08800342293830OneArch Scan BodyHOASB01MU2026-04-02
08800342293847OneArch Scan BodyHOASB02MU2026-04-02
08800342293854OneArch Scan BodyHOASB03MU2026-04-02
08800342293861OneArch Scan BodyHOASB04MU2026-04-02
08800342293878OneArch Scan BodyHOASB05MU2026-04-02
08800342293885OneArch Scan BodyHOASB06MU2026-04-02
08800000987293Bone Screw, Bone TackBSCH14042026-03-09
08800000987309Bone Screw, Bone TackBSCH14062026-03-09
08800000987316Bone Screw, Bone TackBSCH14082026-03-09
08800000987323Bone Screw, Bone TackBSCH20082026-03-09
08800000987330Bone Screw, Bone TackBSCH20102026-03-09
08800000987347Bone Screw, Bone TackBSCH20122026-03-09
08800000987354Bone Screw, Bone TackBSCH20142026-03-09
08800000987361Bone Screw, Bone TackBSCH20162026-03-09
08800040644095Bone ScrewBSCH12032026-03-09
08800040644118Bone ScrewBSCH12042026-03-09
08800040644132Bone ScrewBSCH12052026-03-09
08800040654599Bone Screw, Bone TackOBT32026-03-09
08800040655848OssBuilder SystemSBS2008I2026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235565DRIVER RATCHET RETRIVER M1.6MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
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