FDA Device Registration & Listing · Molndal Vastra Gotaland, SE · Registration 3009632672
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 | 2017-04-19 |
| EZD | Catheter, Straight | Gastroenterology, Urology | Class 2 | 876.5130 | 2012-12-12 |
| OUG | Medical Device Data System | General Hospital | Class 1 | 880.6310 | 2019-12-06 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2011-12-16 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2013-11-20 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2001-10-23 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-11-15 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-11-15 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2012-11-15 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-11-15 |
| EZD | Catheter, Straight | Gastroenterology, Urology | Class 2 | 876.5130 | 2013-01-14 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2013-11-20 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2013-11-20 |
| EZD | Catheter, Straight | Gastroenterology, Urology | Class 2 | 876.5130 | 2022-02-21 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2021-12-16 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-11-15 |
| FBX | Sound, Urethral, Metal Or Plastic | Gastroenterology, Urology | Class 1 | 876.5520 | 2011-12-16 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-11-15 |
| LXB | Hearing Aid, Bone Conduction | Ear, Nose, Throat | Class 2 | 874.3302 | 2023-12-14 |
| EZC | Catheter, Coude | Gastroenterology, Urology | Class 2 | 876.5130 | 2023-05-08 |
| EZD | Catheter, Straight | Gastroenterology, Urology | Class 2 | 876.5130 | 2023-05-08 |
| MAH | Hearing Aid, Bone Conduction, Implanted | Ear, Nose, Throat | Class 2 | 874.3302 | 2023-12-14 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2022-12-07 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2022-12-07 |
| NZU | Collector, Urine, Powered, Non Indwelling Catheter | Gastroenterology, Urology | Class 1 | 876.5250 | 2025-11-20 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-11-15 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2012-11-15 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2012-11-15 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2021-08-27 |
| FCE | Enema Kit | Gastroenterology, Urology | Class 1 | 876.5210 | 2019-12-06 |
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | Class 2 | 876.5980 | 2019-12-06 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2022-12-07 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2022-12-07 |
No official correspondent registered.
| Registration Number | Establishment Name | Location |
|---|---|---|
| 9612618 | DEGUDENT GMBH | Rosbach V.D.H. Hesse, DE |
| 3003756493 | DENTSPLY INDUSTRIA E COMERCIO LTDA | PIRASSUNUNGA Sao Paulo, BR |
| 3001226627 | RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) | ST. EGREVE Isere, FR |
| 3003136642 | OraMetrix GmbH | Berlin Brandenburg, DE |
| 3000303964 | DENTSPLY DENTAL (TIANJIN) CO., LTD. | TEDA Tianjin, CN |
| 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-0004-2013 | Cure Medical LLC | 2 | Male, 16Fr, Straight-tip Intermittent Urinary Catheters M16. The product is distributed individually or in intermediate boxes containing 30 individual, sterile packaged catheters (PA/PE film and dialyzing paper pouches).
There are 30 catheters packaged in sterile pouches that are placed into an intermediate box, 10 of these intermediate boxes packaged into one case. K072539
The Cure Catheter" device, M16, is an intermittent urinary catheter intended to be used by males for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The straight-tip has been designed to eliminate trauma to the urethra and is provided in 16Fr size in an easy-to-open, sterile, single-use package. The coud-tip catheter, M16C, is designed with a curved tip that makes it easier to pass through the curvature of the prostatic urethra in men. It is also used to pass through urethral strictures. This product is prescribed for people who have difficulty or are unable to pass a straight catheter through their urethra and into their bladder. |
| 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. |
| 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 |
3009632672 when referencing this establishment in official correspondence.