FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SEA-BOND
K Number: K863375
·
Decision Sep 19, 1986
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
0
Applicant Total
6
Review Days
16
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Basic Information
- Device Name
- SEA-BOND
- K Number
- K863375
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3450
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Combe, Inc.
- Date Received
- September 3, 1986
- Decision Date
- September 19, 1986
- Product Code
- KXX
- 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 |
|---|---|---|---|
| KXX | Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer | FDA class 1 | Dental |
Other Clearances by Combe, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942203 | OTC DENTURE CLEANSER | Aug 10, 1994 | Substantially Equivalent |
| K925259 | CFR MONOGRAPH | Jan 11, 1993 | Substantially Equivalent |
| K780719 | FUNGUS FIGHTER INSOLES | Oct 10, 1978 | Substantially Equivalent |
| K770413 | CUSHIONS, DENTURE ADHESIVE, ALL-DAY | Jun 24, 1977 | Substantially Equivalent |
| K770175 | SEA-BOND ADHEVISE DENTURE CUSHIONS | Feb 4, 1977 | Substantially Equivalent |