Product code KOT— Dental
DENTURE ADHESIVE SEALS
- Classification name
- Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
- Device class
- Class 1
- Regulation
- 21 CFR 872.3490
- Advisory panel
- Dental
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code KOT
FDA has cleared devices under product code KOT between 1983 and 1994, filed by 7 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1994
- 1990
- 1988
- 1987
- 1986
- 1983
Top applicants under product code KOT
Adverse events under product code KOT
product code KOT- Death
- 5
- Injury
- 309
- Total
- 314
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KOT
- K945462 — SUPER POLI-GRIP DENTURE ADHESIVE CREAM
- K941365 — MPI DENTURE ADHESIVE FILM SEALS
- K903568 — SUPER STRENGTH DENTURE ADHESIVE CREAM
- K895818 — STEADFAST DENTURE ADHESIVE CREAM
- K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM
- K872225 — SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER
- K854430 — RIGIDENT CREAM
- K831493 — DENTURE ADHESIVE SEALS
Data sourced from openFDA. This site is unofficial and independent of the FDA.