Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025338240

FEI Number

3025338240

Entity Name

OSSVIS CO., LTD.

City/State/Country

Anyang-si Gyeonggi, KR

Establishment Address

6F, 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si Gyeonggi 14055, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ossvis Co., Ltd. (Owner Number: 10086315)

Owner / Operator Contact Address

6F, 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, KR-41 14055, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LW Solid Abutment SET LW Retraction Cap LW Vis Abutment SET Surgical Master Kit Lili Guide Kit Surgical Simple Kit 2 Sinus & GBR Kit Lilivis Guide Full Kit Surgical Option Kit Surgical Simple Kit Surgical Simple Kit 3 Surgical Master Kit2 OV Dental Mallet LW UCLA Abutment LW Pre-milled Abutment LW Narrow Pre-milled Abutment Guide Full Lindemann Drill Bone Profile Drill Diamond Reamer Drill Step Drill Crestal Drill Stopper Point Drill Lindemann Drill Harvesting Drill Guide Full Flattening Drill Saw Disc Guide Full Step Drill Straight Round Bur Guide Drill Twist Drill S2 Cortical Drill Guide Full lnitial Drill Round Drill Point Drill Trimming Drill Twist Drill Guide Full Cortical Drill LC Counter Sinking Drill Path Drill Short Cortical Drill Short Step Drill Cortical Drill S2 Short Twist Drill Guide Full Twist Drill Guide Full Anchor Twist Drill OV Freer Elevator LW Implant LW Healing Abutment LW Temporary Abutment LW Implant System LW Solid Abutment LW Abutment Screw LW Cover Screw LW Angled Abutment LW Vis Abutment LW Implant SLA OV Sinus Curette Handle for tips Guide Full Anchor Driver Engine LW Digital Lab Analog GM LW Plastic Impression Coping Sinus Drill Stopper LW Pick-up Impression Coping LW Transfer Impression Coping Bone Splitter 2 LW Scan Body SET Bone Splitter 1 LW Narrow Transfer Impression Coping Guide Pin LW Narrow Pick-up Impression Coping 1.2 Hex Driver Wrench LW Pick-up Impression Coping Guide Pin NoMount Driver Wrench Torque Wrench LW Oss Abutment Driver Engine LW Narrow Scan Body Screw LC NoMount Driver Wrench LL Implant Driver Engine 1.2 Hex Driver Engine LW Oss Abutment Transfer Impression Coping LW Oss Abutment Transfer Impression Coping Guide Pin LL Plastic Impression Coping Parallel Pin LW Scan Body Screw LC Implant Path Pin LC Transfer Impression Coping LW Oss Abutment Driver Wrench LW Scan Body LC Transfer Impression Coping Guide Pin Guide Full NoMount Driver Engine LC Pick-up Impression Coping Guide Pin LL Implant Driver Wrench Guide Full Anchor Pin Implant Path Pin LW Narrow Scan Body LW Oss Abutment Pick-up Impression Coping LC NoMount Driver Engine NoMount Driver Engine LW Narrow Transfer Impression Coping LW Mount Screw Bone Tack Carrier Bone Profile Guide Pin LW Transfer Impression Coping Guide Pin LC Pick-up Impression Coping LW Narrow Pick-up Impression Coping Guide Pin LW Lab Analog Guide Full Anchor Driver Short Wrench Drill Stopper LW Mount Drill Extension LC Solid Abutment Plastic Impression Coping Steel Bowl Screw Remover Tip LW Solid Lab Analog LW Oss Abutment Clearance Gap Gauge LW Oss Abutment Scan Body Screw Drill Stopper S2 Wrench LW Narrow Lab Analog LL Lab Analog Guide Full NoMount Driver Wrench LW Oss Abutment Scan Body LW Oss Abutment Pick-up Impression Coping Guide Pin Bone Tack Case 1.2 Ball HEX Driver Wrench LW Narrow Dirigal Lab Analog GM LW Oss Slot Driver LL Scan Body LC Solid Plus Abutment Plastic Impression Coping LL Driver Separator Depth Gauge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-09-15
OFY	Dental Implant Surgical Tray	Dental	Class 1	872.3980	2023-05-24
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2023-03-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-09-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-12-08
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2023-03-03
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2023-03-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-08-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-08-09
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2023-03-03
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2023-03-29
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2022-10-30
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2023-03-03

Official Correspondent

No official correspondent registered.

US Agent Details

April Lee Business: Withus Group Inc Email: withus6664@gmail.com Phone: (909) 2749971

Related Public Records

Same Entity

Ossvis 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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
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

Similar Registrations

Registration Number	Establishment Name	Location
3013578168	DDS CARIBBEAN CORP	Guaynabo, PR, US
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

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025338240. Last updated year: 2026. Please use registration number 3025338240 when referencing this establishment in official correspondence.