FDA Device Registration & Listing · Santa Maria, CA, US · Registration 2918719
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2017-10-03 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2017-10-03 |
| EBH | Material, Impression Tray, Resin | Dental | Class 1 | 872.3670 | 2016-08-11 |
| EJB | Handle, Instrument, Dental | Dental | Class 1 | 872.4565 | 2023-08-02 |
| NOK | Material, External Aesthetic Restoration, No Adhesive | General, Plastic Surgery | Class 1 | 878.3800 | 2016-08-11 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2023-04-20 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2016-07-28 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2017-10-03 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-11-21 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2023-07-03 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2017-10-03 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2023-08-02 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2017-10-03 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2016-07-28 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-11-21 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2022-10-27 |
| DZA | Drill, Dental, Intraoral | Dental | Class 1 | 872.4130 | 2016-07-28 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-11-21 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-11-21 |
| EID | Syringe, Restorative And Impression Material | Dental | Class 1 | 872.4565 | 2022-10-21 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2017-10-03 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2017-10-03 |
| EGG | Attachment, Precision, All | Dental | Class 1 | 872.3165 | 1986-07-23 |
| PNP | Dental Abutment Design Software For Dental Laboratory | Dental | Class 2 | 872.3630 | 2025-06-10 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-06-10 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2017-10-03 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2023-02-28 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-11-21 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2026-04-28 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2023-01-06 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2023-01-06 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2017-10-03 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 2134751 | YOUNG MICROBRUSH LLC | GRAFTON, WI, US |
| 3027615 | AMERICAN EAGLE INSTRUMENTS | Missoula, MT, US |
| 8022249 | GERMIPHENE CORP. | BRANTFORD Ontario, CA |
| 1941138 | YOUNG DENTAL MANUFACTURING CO 1, LLC. | EARTH CITY, MO, US |
| 2024980 | YOUNG INNOVATIONS INC. | Algonquin, IL, US |
| 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 |
| 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 |
| 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 |
2918719 when referencing this establishment in official correspondence.