FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BA Pit & Fissure Sealant
K Number: K190998
·
Decision Nov 8, 2019
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
15
Review Days
206
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
- BA Pit & Fissure Sealant
- K Number
- K190998
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Apex Dental Materials, Inc.
- Date Received
- April 16, 2019
- Decision Date
- November 8, 2019
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBC), ordered by most recent decision date.
Any-Com Seal
FDA 510(k)
FDA Class 2
·Dental
Parkell Pit and Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
FDA 510(k)
FDA Class 2
·Dental
Enamel Coating Resin
FDA 510(k)
FDA Class 2
·Dental
Helioseal F Plus
FDA 510(k)
FDA Class 2
·Dental
Pulpdent (Activa) Pit and Fissure Sealant with MCP
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Apex Dental Materials, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161077 | RnD TE and RnD SE | Mar 17, 2017 | Substantially Equivalent |
| K131043 | APEX UNIVERSAL ADHESIVE | Sep 10, 2013 | Substantially Equivalent |
| K131049 | ZRP | Aug 27, 2013 | Substantially Equivalent |
| K120620 | CLEAN AND BOOST | May 31, 2012 | Substantially Equivalent |
| K110859 | METAL OPAQUER | Jun 23, 2011 | Substantially Equivalent |
| K092539 | SEAMFREE | Oct 1, 2009 | Substantially Equivalent |
| K091647 | INJECTAFIL | Sep 21, 2009 | Substantially Equivalent |
| K062157 | CONFORM | Oct 13, 2006 | Substantially Equivalent |
| K061981 | SURPASS | Jul 31, 2006 | Substantially Equivalent |
| K053103 | INTERFACE | Feb 1, 2006 | Substantially Equivalent |