FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APEX UNIVERSAL ADHESIVE
K Number: K131043
·
Decision Sep 10, 2013
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
15
Review Days
148
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Basic Information
- Device Name
- APEX UNIVERSAL ADHESIVE
- K Number
- K131043
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Apex Dental Materials, Inc.
- Date Received
- April 15, 2013
- Decision Date
- September 10, 2013
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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|---|---|---|---|
| K190998 | BA Pit & Fissure Sealant | Nov 8, 2019 | Substantially Equivalent |
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| 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 |