Product code KCZ
- Device name
- Prosthesis, Breast, External, Used With Adhesive
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.3800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990458 | STRAUMANN EXTRAORAL IMPLANT SYSTEM | Straumann USA | 1999-04-16 |
| K951324 | MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESIS | Maxol Limited L.C. | 1995-05-26 |
| K933465 | COSMET | Great Bay Medical Products, Inc. | 1994-07-20 |
| K932978 | CALSSIQUE OR MYSTIQUE | Dekumed, Kunststofftechnik Degler GmbH | 1993-12-22 |
| K932899 | CLASSIQUE | Hemispheres Marketing Co. , Ltd. | 1993-12-16 |
| K933668 | ALMOST U, INC. BREAST PROSTHESIS | Almost U., Inc. | 1993-12-10 |
| K921535 | SUOENA AFFINITY (TM) MODEL #802 | Coloplast Corp. | 1992-05-11 |
| K915382 | AMOENA AFFINITY MODEL #802 | Coloplast Corp. | 1992-01-14 |
| K911247 | YOURS TRULY ASYMMETRICAL BREAST FORM | Jobst Institute, Inc. | 1991-03-29 |
| K904085 | ELLA BREAST FORM | Coloplast A/S | 1990-10-31 |
| K904316 | NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT | Coloplast Corp. | 1990-10-11 |
| K904086 | DISCRENE SELF-SUPPORTING BREAST FORM | Coloplast A/S | 1990-10-02 |
| K896533 | SPENCO BREAST FORMS | Spenco Medical Corp. | 1989-12-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810008657911 | ABC Diamond Attach | AMERICAN BREAST CARE, L.P. | 2026-10-09 |
| 00810008657928 | ABC Diamond Attach | AMERICAN BREAST CARE, L.P. | 2026-10-09 |
| 00810008657935 | ABC Diamond Attach | AMERICAN BREAST CARE, L.P. | 2026-10-09 |
| 00810008657942 | ABC Diamond Attach | AMERICAN BREAST CARE, L.P. | 2026-10-09 |
| 00810008657959 | ABC Diamond Attach | AMERICAN BREAST CARE, L.P. | 2026-10-09 |
| 00810008657966 | ABC Diamond Attach | AMERICAN BREAST CARE, L.P. | 2026-10-09 |
| 00810008657973 | ABC Diamond Attach | AMERICAN BREAST CARE, L.P. | 2026-10-09 |
| 00810008657980 | ABC Diamond Attach | AMERICAN BREAST CARE, L.P. | 2026-10-09 |
| 00810008657997 | ABC Diamond Attach | AMERICAN BREAST CARE, L.P. | 2026-10-09 |
| 00810008657904 | ABC Diamond Attach | AMERICAN BREAST CARE, L.P. | 2026-10-09 |
| ESTOI0207Z4300 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2026-09-28 |
| ESTOI0206X5200 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2025-10-08 |
| ESTOH0004Z40 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2023-07-24 |
| ESTOH0004Z30 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2023-07-24 |
| ESTOH0004Z20 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2023-07-24 |
| ESTOH0004K10 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2023-07-24 |
| ESTOH0004X10 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2023-07-24 |
| 07630031718181 | Straumann Extraoral Implant System | Institut Straumann AG | 2022-12-02 |
| 07630031718198 | Straumann Extraoral Implant System | Institut Straumann AG | 2022-12-02 |
| 07630031724823 | Straumann Extraoral Implant System | Institut Straumann AG | 2022-12-02 |
| 07630031718211 | Straumann Extraoral Implant System | Institut Straumann AG | 2022-12-02 |
| 07630031718204 | Straumann Extraoral Implant System | Institut Straumann AG | 2022-12-02 |
| ESTOI0201K3000 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2019-06-06 |
| ESTOH0004X40 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2018-03-26 |
| ESTOA0002Z6950 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2018-03-26 |
| ESTOI0201X5000 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2018-03-26 |
| ESTOI0201X6500 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2018-03-26 |
| ESTOI0201Z4750 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2018-03-26 |
| ESTOI0201Z6000 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2018-03-26 |
| ESTOH1101X10 | StecoTitanmagnetics® | steco-System-Technik GmbH & Co KG | 2018-02-12 |