FDA.reportPublic FDA data

Convex Osteotome

Primary DI
08809918209862
Brand
Convex Osteotome
Company
Ossvis Co., Ltd.
Model
HSOT35
Device description
Dental Implant Surgical Instrument - Osteotome
Published
2023-12-16
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

Product Codes#

Code, Name table
CodeName
EMMChisel, Osteotome, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMMChisel, Osteotome, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809918209862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809918209862088099182098628809918209862

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
695365503
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
08809918249837Steel BowlHSB2023-12-18
08809918249844Bone Tack CaseHSBTC2023-12-18
08809918209619Bone Tack CarrierHSBC2023-12-15
08809918273252LW Oss Abutment Driver EngineHLWORSE2024-10-25
08809918273269LW Oss Abutment Driver WrenchHLWORSW2024-10-25
08809918273436LW Oss Abutment Scan BodyLWOSB455HS2024-10-25
08809918273443LW Oss Abutment Scan BodyLWOSB455NS2024-10-25
08809918273450LW Oss Abutment Scan BodyLWOSB458HS2024-10-25
08809918273467LW Oss Abutment Scan BodyLWOSB458NS2024-10-25
08809918273474LW Oss Abutment Scan BodyLWOSB555HS2024-10-25
08809918273481LW Oss Abutment Scan BodyLWOSB555NS2024-10-25
08809918273498LW Oss Abutment Scan BodyLWOSB558HS2024-10-25
08809918273504LW Oss Abutment Scan BodyLWOSB558NS2024-10-25
08809918254947LW Oss Abutment Pick-up Impression CopingLWOPI45H2024-08-01
08809918254954LW Oss Abutment Pick-up Impression CopingLWOPI45HS2024-08-01
08809918254961LW Oss Abutment Pick-up Impression CopingLWOPI45N2024-08-01
08809918254978LW Oss Abutment Pick-up Impression CopingLWOPI45NS2024-08-01
08809918254985LW Oss Abutment Pick-up Impression CopingLWOPI55H2024-08-01
08809918254992LW Oss Abutment Pick-up Impression CopingLWOPI55HS2024-08-01
08809918255005LW Oss Abutment Pick-up Impression CopingLWOPI55N2024-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398705MillenniumAvalign Technologies, Inc.EMM2026-07-16
08809918209879Convex OsteotomeOssvis Co., Ltd.EMM2023-12-16
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ESAM13290021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13290041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13291041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13310061STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13311061STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333011STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333021STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333031STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333041STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333051STOMA®Storz am Mark GmbHEMM2020-08-27
ESAM13333061STOMA®Storz am Mark GmbHEMM2020-08-27
04038653148998AESCULAPAesculap AGEMM2020-04-21
10649111069406Sklar®SKLAR CORPORATIONEMM2018-10-22