OssBuilder System

GUDID 08809917095275

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08809917095275
NIH Device Record Keyfa9dfe62-ef4b-4000-aaf1-0989cb97bbc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameOssBuilder System
Version Model NumberOBAC352516
Company DUNS689051793
Company NameOsstem Implant Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809917095275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, implant, dental, endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-13
Device Publish Date2023-11-04

On-Brand Devices [OssBuilder System]

08800000979090SMHI530USW
08800000979083SMHI530USP
08800000979076SMHI525USW
08800000979069SMHI525USP
08800000979052SMHI520USW
08800000979045SMHI520USP
08800000979038SMHI515USW
08800000979021SMHI515USP
08800000979014SMHI510USW
08800000979007SMHI510USP
08800000978994SMHI430USR
08800000978987SMHI425USR
08800000978970SMHI420USR
08800000978963SMHI415USR
08800000978956SMHI410USR
08800000978949SMHI330USM
08800000978932SMHI325USM
08800000978925SMHI320USM
08800000978918SMHI315USM
08800000978901SMHI310USM
08800000978895SMCC415
08800000978734SBHC5040
08800000978727SBHC5030
08800000978710SBHC4040
08800000978703SBHC4030
08800000978697SBCC4000
08800000978680SBAC4030TSR
08800000978673SBAC4025TSR
08800000978666SBAC4020TSR
08800000978659SBAC4015TSR
08800000978642SBAC4010TSR
08800000978635SBAC4005TSR
08800000978628SBAC4000TSR
08800000978611SBAC3530TSM
08800000978604SBAC3525TSM
08800000978598SBAC3520TSM
08800000978581SBAC3515TSM
08800000978574SBAC3510TSM
08800000978567SBAC3505TSM
08800000978550SBAC3500TSM
08800000978420OBAC533020
08800000978413OBAC532520
08800000978406OBAC532020
08800000978390OBAC531520
08800000978383OBAC531020
08800000978376OBAC530520
08800000978369OBAC530020
08800000978352OBAC503018
08800000978345OBAC502518
08800000978338OBAC502018

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