FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
K Number: K032603
·
Decision Oct 7, 2003
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
142
Applicant Total
21
Review Days
43
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
- METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING
- K Number
- K032603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3820
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meta Biomed Co., Ltd.
- Date Received
- August 25, 2003
- Decision Date
- October 7, 2003
- Product Code
- KIF
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KIF), ordered by most recent decision date.
Any-Paste
FDA 510(k)
FDA Class 2
·Dental
ZenSeal Pro
FDA 510(k)
FDA Class 2
·Dental
Root canal repair materials (nRoot BP)
FDA 510(k)
FDA Class 2
·Dental
Well-Root PT
FDA 510(k)
FDA Class 2
·Dental
One-Fil Putty Injectable
FDA 510(k)
FDA Class 2
·Dental
MTA vpt
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Meta Biomed Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242014 | Jet Flow Bulk | Oct 8, 2024 | Substantially Equivalent |
| K232299 | CeraPutty | Sep 29, 2023 | Substantially Equivalent |
| K230010 | ADSEAL Plus | Apr 13, 2023 | Substantially Equivalent |
| K230009 | EZ Bond Universal | Mar 3, 2023 | Substantially Equivalent |
| K210904 | Metapaste Plus | Jun 30, 2021 | Substantially Equivalent |
| K202617 | Metapex Plus | Apr 14, 2021 | Substantially Equivalent |
| K191991 | Ezfil | Mar 5, 2020 | Substantially Equivalent |
| K190724 | MD-Temp Plus | Jul 3, 2019 | Substantially Equivalent |
| K190503 | CeraSeal | Jun 7, 2019 | Substantially Equivalent |
| K190510 | GuttaSil | May 29, 2019 | Substantially Equivalent |