Super Poli-Grip Denture Adhesive Cream
FDA 510(k) K945462 · Block Drug Company, Inc.
510(k) numberK945462
Submission
- Device name
- Super Poli-Grip Denture Adhesive Cream
- Applicant
- Block Drug Company, Inc.
Jersey City, NJ, US - Received
- November 7, 1994
- Decision date
- December 20, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KOT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K854430 | Rigident CreamKOT · Traditional | Armkel, LLC | 03/04/1986SE |
| K831493 | Denture Adhesive SealsKOT · Traditional | Johnson & Johnson Professionals, Inc. | 06/30/1983SE |
More from Johnson & Johnson Professionals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K935925 | Vision Prophy Paste with FluorideEJR · Traditional | 01/26/1994SE |
| K933893 | Vision Prophy Paste Without FluorideEJR · Traditional | 11/16/1993SE |
| K884533 | Sensodyne Sealant Dentin Conditioning SystemKLE · Traditional | 04/12/1989SE |
| K881974 | Proficient(Tm) Prophylaxis AngleEFB · Traditional | 07/25/1988SE |
| K872225 | Super Poli-Grip & Wernet's Denture Adhes. PowderKOT · Traditional | 06/30/1987SE |
| K862876 | New Super Poli-Grip Denture Adhesive CreamKOO · Traditional | 08/29/1986SE |
| K800831 | Py-Co-Prox TM Dental BrushEFW · Traditional | 05/08/1980SE |
| K791064 | Duo Two Layer Denture CleanserEFT · Traditional | 10/09/1979SE |
| K780849 | Dentrol Liquid Denture Adhesive · Traditional | 07/31/1978SE |
Questions and answers
When was Super Poli-Grip Denture Adhesive Cream cleared by the FDA?
Super Poli-Grip Denture Adhesive Cream (K945462) received a 510(k) decision of Substantially Equivalent on December 20, 1994, 43 days after the submission was received.
What is the product code of K945462?
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.