FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTURE ADHESIVE SEALS
K Number: K831493
·
Decision Jun 30, 1983
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
7
Applicant Total
206
Review Days
51
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Basic Information
- Device Name
- DENTURE ADHESIVE SEALS
- K Number
- K831493
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3490
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- May 10, 1983
- Decision Date
- June 30, 1983
- 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.
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MPI DENTURE ADHESIVE FILM SEALS
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SUPER STRENGTH DENTURE ADHESIVE CREAM
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STEADFAST DENTURE ADHESIVE CREAM
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PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM
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SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER
FDA 510(k)
FDA Class 1
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| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | Dec 4, 1998 | Substantially Equivalent |
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| K983014 | SUMMIT ACETABULAR SYSTEM | Oct 27, 1998 | Substantially Equivalent |
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| K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | Jul 1, 1998 | Substantially Equivalent |
| K980801 | J-FX BIPOLAR HEAD | May 29, 1998 | Substantially Equivalent |