Sea-Bond Adhevise Denture Cushions
FDA 510(k) K770175 · Combe, Inc.
510(k) numberK770175
Submission
- Device name
- Sea-Bond Adhevise Denture Cushions
- Applicant
- Combe, Inc.
Mchenry, IL, US - Received
- January 26, 1977
- Decision date
- February 4, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KKX – Drape, Surgical, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
Other 510(k)s with product code KKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial IIKKX · Traditional | Avery Dennison Medical , Ltd. | 10/25/2023SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 3M Company | 05/18/2023SE |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobialKKX · Traditional | Avery Dennison Belgie Bvba | 07/30/2021SE |
| K200238 | ControlRad Sterile CoverKKX · Traditional | Controlrad, Inc. | 04/26/2020SE |
| K163556 | MediClear PreOpKKX · Traditional | Covalontechnologies, Inc. | 09/14/2017SE |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXXKKX · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 06/24/2015SE |
| K141324 | Hongyu Disposable Surgical DrapesKKX · Traditional | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 04/14/2015SE |
| K140195 | Surgical DrapeKKX · Traditional | Griffith-Lucas, LLC | 09/10/2014SE |
| K140330 | 3M Steri-Drape Fabric Surgical DrapesKKX · Traditional | 3M Healthcare | 08/18/2014SE |
| K141438 | Whitney Medical Solutions EshieldKKX · Traditional | Whitney Medical Solutions | 08/14/2014SE |
More from Whitney Medical Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K171855 | External Moisturizing GelNUC · Special | 07/21/2017SE |
| K150615 | Vaginal Moisturizing GelNUC · Traditional | 05/01/2015SE |
| K141718 | Internal Hydrating GelNUC · Traditional | 11/13/2014SE |
| K942203 | OTC Denture CleanserEFT · Traditional | 08/10/1994SE |
| K925259 | CFR MonographEFT · Traditional | 01/11/1993SE |
| K863375 | Sea-BondKXX · Traditional | 09/19/1986SE |
| K780719 | Fungus Fighter InsolesKYS · Traditional | 10/10/1978SE |
| K770413 | Cushions, Denture Adhesive, All-DayEHS · Traditional | 06/24/1977SE |
Questions and answers
When was Sea-Bond Adhevise Denture Cushions cleared by the FDA?
Sea-Bond Adhevise Denture Cushions (K770175) received a 510(k) decision of Substantially Equivalent on February 4, 1977, 9 days after the submission was received.
What is the product code of K770175?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.