Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014938434

FEI Number

3014938434

Entity Name

UNIQA DENTAL LTD

City/State/Country

Netanya Central, IL

Establishment Address

2 Ha-Tsoran street, Entrance A, 2nd Floor, Netanya Central 4250602, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

UNIQA DENTAL LTD (Owner Number: 10058710)

Owner / Operator Contact Address

2 Ha-Tsoran street, Netanya, IL-NOTA 4250602, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Straight Multi Unit Abutment, MUA, C-type/Straight multi unit abutment D-type Straight abutment, wide Screw for abutment 15 angled abutment/15 abutment H- Internal Hex RP Screw for Multi Unit Abutment sleeve, V-type Screw for MUA sleeve, C-type Implant Internal Hex SMART Dental Implants System Set 17 angled Multi Unit Abutment, MUA, D-type, Castable Sleeve Conical Implant, Internal Hex, Pure & Porous, P&P Healing cap for Multi Unit Abutment, MUA, V-type Transfer Abutment Regular/Straight abutment RP Healing cap, wide 25 angled abutment/25 abutment H- Internal Hex RP Straight Multi Unit Abutment, MUA, V-type/Straight multi unit abutment V-type GH- Internal Hex RP Conical Implant, SBA Locator abutment/DLOC attachment abutment Transfer Abutment Mini Conical Implant, Internal Hex, SBA Sleeve for Multi Unit Abutment, MUA, Temporary, V-type Silicone cap for locator/DLOC, Soft Straight Multi Unit Abutment, MUA, D-type/Straight multi unit abutment D-type GH- Internal Hex RP 25 angled anatomic abutment/25 abutment with shoulder Sleeve for Multi Unit Abutment, MUA, Temporary, D-type Conical Implant, Pure & Porous, P&P Implant Conical Ball attachment abutment Screw Mini Conical Screw for angled MUA, D-type Healing Cap Mini/MP Healing Cap Regular Healing cap, regular Silicone cap for locator/DLOC, Strong Set 30 angled Multi Unit Abutment, MUA, D-type, Temporary Sleeve Set 30 angled Multi Unit Abutment, MUA, D-type, Castable Sleeve Screw Regular Conical 17 angled Multi Unit Abutment, MUA, D-type/17 multi unit abutment D-type GH- Internal Hex RP Straight anatomic abutment Sleeve for Multi Unit Abutment, MUA, Fixed, C-type Metal cap/housing for ball attachment/DLOC Sleeve for Multi Unit Abutment, MUA, Rotation, C-type Straight abutment with shoulder, regular 30 angled Multi Unit Abutment, MUA, D-type/30 multi unit abutment D-type GH- Internal Hex RP 15 angled anatomic abutment/15 abutment with shoulder Healing cap for MUA, D-type Metal cap for locator Healing cap, narrow SMART Israel Dental Solutions Implants System Straight abutment with shoulder, wide Silicone cap for locator/DLOC, Standard Screw for MUA sleeve, D-type Silicone cap for ball attachment Straight abutment, regular Snap on transfer Set 17 angled Multi Unit Abutment, MUA, D-type, Temporary Sleeve Drills with external irrigation Drill extender Countersink, one size Drill with integral stoppers Drill extender, internal irrigation Conical drills with external irrigation Twist drill, coated Drill stopper Drills with internal irrigation Trephine burr Marking drill Step drills, coated Tissue punch Round burr Countersink, two sizes Lance drill Marking drill, internal irrigation Ratchet screw driver hex 2mm Snap on transfer Castable straight abutment hex Implant analog plus Transfer for Multi Unit Abutment MUA V-type Contra angle key for straight MUA D-type Cap for Snap on transfer Scan body implant level Castable abutment round Digital implant analog Transfer for Multi Unit Abutment MUA D-type Transfer closed tray wide Handle for Angled MUA D-Type Duplicator Dentists Transfer Manual implant driver hex Castable straight abutment round Depth probe Castable abutment hex Implant analog Transfer open tray Ratchet screw driver hex 1.27mm Duplicator Magnet Cap Contra-angle driver for implants Implant Analog Mini Conical Convenient Surgical Kit Box Ratchet screw driver for abutment Nut for digital analog Bite index Ratchet screw driver hex 2.5mm Ratchet wrench Screw for scan body MUA level Implant analog for Multi Unit Abutment MUA D-type Plastic Castable Conical Abutment Regular Manual screw driver hex Sleeve for Multi Unit Abutment MUA Castable C-type Parallel pin Double sided Short Symmetry Contra angle key for straight MUA C-type Transfer open tray narrow Screw for MUA transfer D-type Implant Analog Regular Conical Ratchet key for straight MUA C-type Implant analog for Multi Unit Abutment MUA V-type Sleeve for Multi Unit Abutment MUA Castable D-type Ratchet screw driver for implants 2.4mm Carrier for Straight MUA C-Type Sleeve for Multi Unit Abutment MUA Castable V-type Transfer open tray wide Torque ratchet wrench Impression ring for locator Click transfer closed tray Screw for Transfer Closed tray Manual implant driver 6.35mm Surgical guide Sleeve Duplicator Dentists Transfer 1mm Extractor for angled MUA Ratchet screw driver hex, 1.2mm Implant analog plus angled Parallel pin Double sided Long Symmetry Plastic Castable Conical Abutment Mini Castable anatomic abutment hex Screw for scan body Contra-angle driver for abutments Screw for Transfer Open tray Transfer Open tray slim Manual punch tool 4mm Impression ring for ball attachment Ratchet key for straight MUA D-type Digital analog Transfer closed tray Ratchet screw driver for implants 2.1mm

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	2018-10-23
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-10-23
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2018-10-23
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2018-10-23

Official Correspondent

No official correspondent registered.

US Agent Details

Daniela Levy Business: Sterling Medical Registration Email: office@sterlingmedicalregistration.com Phone: (213) 7873026

Related Public Records

Same Entity

UNIQA DENTAL 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 3014938434. Last updated year: 2026. Please use registration number 3014938434 when referencing this establishment in official correspondence.