FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEETHMATE-A
K Number: K897027
·
Decision Mar 14, 1990
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
25
Review Days
86
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Basic Information
- Device Name
- TEETHMATE-A
- K Number
- K897027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Kuraray Co.
- Date Received
- December 18, 1989
- Decision Date
- March 14, 1990
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
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Other Clearances by Kuraray Co.
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|---|---|---|---|
| K990040 | CLEARFIL SE BOND | Feb 4, 1999 | Substantially Equivalent |
| K951813 | CARIES DETECTOR | Jul 11, 1995 | Substantially Equivalent |
| K933030 | PANAVIA 21 | Feb 24, 1994 | Substantially Equivalent |
| K925383 | PHOTO CLEARFIL OPAQUER | Jan 28, 1993 | Substantially Equivalent |
| K925404 | CLEARFIL PORCELAIN BOND ACTIVATOR | Jan 11, 1993 | Substantially Equivalent |
| K912708 | CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM | Aug 20, 1991 | Substantially Equivalent |
| K912707 | CLEARFIL LINER BOND SYSTEM | Aug 20, 1991 | Substantially Equivalent |
| K910424 | TEETHMATE-F | Apr 3, 1991 | Substantially Equivalent |
| K900690 | CLEARFIL VENEER BOND KIT | Apr 13, 1990 | Substantially Equivalent |
| K890123 | CLEARFIL CR INLAY | Mar 31, 1989 | Substantially Equivalent |