FDA Device Registration & Listing · Escondido, CA, US · Registration 3006796211
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2013-03-04 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-02-14 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2016-03-10 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2024-06-18 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2015-07-22 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2013-04-11 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2023-06-08 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2015-10-23 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 1992-12-02 |
| EGG | Attachment, Precision, All | Dental | Class 1 | 872.3165 | 1992-12-02 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-11-20 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2023-06-08 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-09-18 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2023-06-08 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 1992-12-02 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3010664129 | Danville Materials Research Center | Anaheim, CA, US |
| 2023950 | ZEST ANCHORS, LLC | Carlsbad, CA, US |
| 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 |
| 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. |
| 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 |
3006796211 when referencing this establishment in official correspondence.