FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIGIDENT CREAM
K Number: K854430
·
Decision Mar 4, 1986
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
7
Applicant Total
68
Review Days
119
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- RIGIDENT CREAM
- K Number
- K854430
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3490
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Armkel, LLC
- Date Received
- November 5, 1985
- Decision Date
- March 4, 1986
- Product Code
- KOT
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KOT), ordered by most recent decision date.
SUPER POLI-GRIP DENTURE ADHESIVE CREAM
FDA 510(k)
FDA Class 1
·Dental
MPI DENTURE ADHESIVE FILM SEALS
FDA 510(k)
FDA Class 1
·Dental
SUPER STRENGTH DENTURE ADHESIVE CREAM
FDA 510(k)
FDA Class 1
·Dental
STEADFAST DENTURE ADHESIVE CREAM
FDA 510(k)
FDA Class 1
·Dental
PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Dental
SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Armkel, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K040866 | FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST | Oct 19, 2004 | Substantially Equivalent |
| K030258 | FIRST RESPONSE PREGNANCY TEST | Feb 25, 2003 | Substantially Equivalent |
| K023405 | TROJAN MINT TINGLE BRAND LATEX CONDOMS | Dec 16, 2002 | Substantially Equivalent |
| K013433 | TROJAN PASSION BERRY GEL | Mar 5, 2002 | Substantially Equivalent |
| K013614 | TROJAN CRYSTAL CLEAR LIQUID | Feb 1, 2002 | Substantially Equivalent |
| K001212 | TROJAN EXTRA LARGE LATEX CONDOM | May 9, 2000 | Substantially Equivalent |
| K000748 | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | Apr 6, 2000 | Substantially Equivalent |
| K992232 | FIRST RESPONSE 1-STEP PREGNANCY | Dec 21, 1999 | Substantially Equivalent |
| K973352 | BRAND NAME *1-STEP PREGNANCY | Oct 27, 1997 | Substantially Equivalent |
| K973310 | TBD* ONE-STEP OVULATION PREDICTOR TEST | Oct 27, 1997 | Substantially Equivalent |