FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TheraBase, TheraBase Ca
K Number: K192007
·
Decision Mar 17, 2020
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
88
Review Days
232
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Basic Information
- Device Name
- TheraBase, TheraBase Ca
- K Number
- K192007
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bisco, Inc.
- Date Received
- July 29, 2019
- Decision Date
- March 17, 2020
- 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 Bisco, Inc.
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|---|---|---|---|
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| K182917 | FluoroCal | Nov 18, 2019 | Substantially Equivalent |
| K180344 | TheraCal DC | Apr 5, 2018 | Substantially Equivalent |
| K171147 | REVEAL Bulk | Aug 4, 2017 | Substantially Equivalent |
| K162598 | HAPI Seal | May 23, 2017 | Substantially Equivalent |
| K163171 | CeraClean | Apr 14, 2017 | Substantially Equivalent |
| K161051 | All-Bond Universal w/BAC (not finalized) | Sep 9, 2016 | Substantially Equivalent |
| K161256 | TheraCem | Jul 29, 2016 | Substantially Equivalent |
| K143292 | TheraCal DC | Aug 4, 2015 | Substantially Equivalent |