FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOKUYAMA M-BOND
K Number: K011854
·
Decision Sep 4, 2001
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
22
Review Days
83
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Basic Information
- Device Name
- TOKUYAMA M-BOND
- K Number
- K011854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tokuyama America, Inc.
- Date Received
- June 13, 2001
- Decision Date
- September 4, 2001
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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Other Clearances by Tokuyama America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K022641 | TOKUYAMA REBASE II | Oct 2, 2002 | Substantially Equivalent |
| K011685 | BISTITE II DC | Jul 31, 2001 | Substantially Equivalent |
| K010267 | PALFIQUE ESTELITE LV CLEAR | Feb 27, 2001 | Substantially Equivalent |
| K002863 | PALFIQUE ESTELITE LV | Jan 4, 2001 | Substantially Equivalent |
| K993917 | TOKUYAMA ONE-UP-BOND F | Feb 2, 2000 | Substantially Equivalent |
| K991711 | BISTITE II SC | Jul 7, 1999 | Substantially Equivalent |
| K982537 | TOKUYAMA SOFRELINER | Aug 24, 1998 | Substantially Equivalent |
| K980054 | PALFIQUE ESTELITE | Apr 27, 1998 | Substantially Equivalent |
| K980058 | TOKUSO MAC BOND II | Apr 27, 1998 | Substantially Equivalent |
| K980051 | PALFIQUE ESTELITE PASTE | Feb 24, 1998 | Substantially Equivalent |