FDA.report

Osteotome Mallet

Primary DI
08800209371619
Brand
Osteotome Mallet
Company
Osstem Implant Co., Ltd.
Model
HOSTM
Published
2023-08-07
Public version status
New
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
EIFAccessories, Retractor, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800209371619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800209371619088002093716198800209371619

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
689051793
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DIBrandModelCatalogPublished
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
08800040655862OssBuilder SystemSBS2010I2026-03-09
08800040655886OssBuilder SystemSBS2011I2026-03-09
08800040655909OssBuilder SystemSBS2013I2026-03-09
08809892366858SS Abutment SystemSSCAP4814CTH2026-03-09
08809892366896SS Abutment SystemSSCAP4824CTH2026-03-09
08809892366957SS Abutment SystemSSCAP4826ENTH2026-03-09
08809892366964SS Abutment SystemSSCAP4826ETH2026-03-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04251436943836KOHLERKohler Medizintechnik GmbHEIF2026-03-12
00840479200040CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00840479200057CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00810042124875OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIF2026-01-28
D248938520Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
07630716617037Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616382Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616399Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617051Geistlich PanoramaDSSM AGEIF2025-09-17
00840456215074JMUJMU DENTAL, INCEIF2025-07-15
00860013984601TissuePro™ Distal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984618TissuePro™ Proximal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984625TissuePro™ Single Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984632TissuePro™ Distal Sleeve, MN Retractor Single-UseArmor Dental Corp.EIF2025-05-12
08800099963765Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963772Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963789Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963796Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963802Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963819Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963826Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963833Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963840Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963857Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963864Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963871Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963888Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963895Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963901Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963918Perfit ZRVatech mcis Co., LtdEIF2025-04-07