Rigident Cream
FDA 510(k) K854430 · Armkel, LLC
510(k) numberK854430
Submission
- Device name
- Rigident Cream
- Applicant
- Armkel, LLC
Cranbury, NJ, US - Received
- November 5, 1985
- Decision date
- March 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KOT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945462 | Super Poli-Grip Denture Adhesive CreamKOT · Traditional | Block Drug Company, Inc. | 12/20/1994SE |
| K941365 | Mpi Denture Adhesive Film SealsKOT · Traditional | Medical Polymers, Inc. | 04/22/1994SE |
| K903568 | Super Strength Denture Adhesive CreamKOT · Traditional | Teledyne Getz | 10/24/1990SE |
| K895818 | Steadfast Denture Adhesive CreamKOT · Traditional | Stiefel Research Institute, Inc. | 04/03/1990SE |
| K884357 | Precision Bioport Collection & Transport SystemKOT · Traditional | Precision Dynamics Corp. | 11/01/1988SE |
| K872225 | Super Poli-Grip & Wernet's Denture Adhes. PowderKOT · Traditional | Block Drug Company, Inc. | 06/30/1987SE |
| K831493 | Denture Adhesive SealsKOT · Traditional | Johnson & Johnson Professionals, Inc. | 06/30/1983SE |
More from Johnson & Johnson Professionals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K040866 | First Response One-Step Digital Pregnancy TestLCX · Traditional | 10/19/2004SE |
| K030258 | First Response Pregnancy TestLCX · Traditional | 02/25/2003SE |
| K023405 | Trojan Mint Tingle Brand Latex CondomsHIS · Abbreviated | 12/16/2002SE |
| K013433 | Trojan Passion Berry GelNUC · Traditional | 03/05/2002SE |
| K013614 | Trojan Crystal Clear LiquidNUC · Traditional | 02/01/2002SE |
| K001212 | Trojan Extra Large Latex CondomHIS · Special | 05/09/2000SE |
| K000748 | Trojan Latex Condom with Male Genital Desensitizer LubricantHIS · Special | 04/06/2000SE |
| K992232 | First Response 1-STEP PregnancyLCX · Traditional | 12/21/1999SE |
| K973352 | Brand Name *1-STEP PregnancyLCX · Traditional | 10/27/1997SE |
| K973310 | Tbd* One-Step Ovulation Predictor TestCEP · Traditional | 10/27/1997SE |
Questions and answers
When was Rigident Cream cleared by the FDA?
Rigident Cream (K854430) received a 510(k) decision of Substantially Equivalent on March 4, 1986, 119 days after the submission was received.
What is the product code of K854430?
The FDA product code is KOT – Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium, a Class I (low risk) device regulated under 21 CFR 872.3490.