Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009611645

FEI Number

3009611645

Entity Name

BIOTEM CO., LTD.

City/State/Country

Busan, KR

Establishment Address

# 422, Sasang-ro, Sasang-gu, Busan 46925, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biotem Co., Ltd. (Owner Number: 10057313)

Owner / Operator Contact Address

# 422, Sasang-ro, Sasang-gu, Busan, KR-26 46925, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AR_N Type Implant System Primus Implant System AR_N Hand Driver Hand Driver IR Pick-Up Impression Coping BR Hand Driver Torque Wrench BR Pick-Up Impression Coping BR Transfer Impression Coping Transfer Impression Coping AR_N Fixture Lab Analog AR_N Transfer Impression Coping IR Fixture Lab Analog AR_N Solid Lab Analog Fixture Lab Analog Solid Lab Analog Pick-Up Impression Coping AR_N Pick-Up Impression Coping IR Solid Lab Analog BR Lab Analog BR Type Implant System Marking Drill Tapered Drill Point Drill Straight Drill Cortical Drill Drill Extension BR SLA Type Implant System IR Type Implant System IR Fixture Driver for Wrench IR Fixture Driver for Machine AR_N Fixture Driver for Machine Fixture Driver for Machine BR Fixture Driver for Machine AR_N Fixture Driver for Wrench BR Fixture Driver for Wrench Fixture Driver for Wrench

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-03-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-03-19
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2018-03-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-03-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-03-19
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2018-03-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-08-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-08-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-03-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-03-19
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2018-03-19

Official Correspondent

No official correspondent registered.

US Agent Details

Eunjin Yuwm Business: BIOTEM USA Email: aoiyuwm@biotemusa.com Phone: (310) 4087630

Related Public Records

Same Entity

Biotem Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

Similar Registrations

Registration Number	Establishment Name	Location
3030690317	TRATE LLC	Tamarac, FL, US
3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT
3040978916	NUVENTUS B.V.	Venlo Limburg, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009611645. Last updated year: 2026. Please use registration number 3009611645 when referencing this establishment in official correspondence.