Apex Dental Materials, Inc.
Schaumburg, IL, US
Apex Dental Materials, Inc. appears in FDA device records in Schaumburg, IL. FDA records list 15 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Apex Dental Materials, Inc. between 2001 and 2019. The busiest year on record is 2001, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 3 |
| 2002 | 1 |
| 2006 | 3 |
| 2009 | 2 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2017 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K190998 | BA Pit & Fissure Sealant | EBC | Substantially Equivalent | |
| K161077 | RnD TE and RnD SE | KLE | Substantially Equivalent | |
| K131043 | APEX UNIVERSAL ADHESIVE | KLE | Substantially Equivalent | |
| K131049 | ZRP | KLE | Substantially Equivalent | |
| K120620 | CLEAN AND BOOST | KLE | Substantially Equivalent | |
| K110859 | METAL OPAQUER | EBF | Substantially Equivalent | |
| K092539 | SEAMFREE | EBF | Substantially Equivalent | |
| K091647 | INJECTAFIL | EBF | Substantially Equivalent | |
| K062157 | CONFORM | EBF | Substantially Equivalent | |
| K061981 | SURPASS | KLE | Substantially Equivalent | |
| K053103 | INTERFACE | KLE | Substantially Equivalent | |
| K020570 | SIMPLICITY | KLE | Substantially Equivalent | |
| K010849 | VERTEX ETCHANT | EBF | Substantially Equivalent | |
| K010547 | VERTEX SEALAND L/C ORTHODONTIC SEALANT | KLE | Substantially Equivalent | |
| K010544 | VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE | DYH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain