Ivoclar USA, Inc.
Amherst, NY, US
Ivoclar USA, Inc. appears in FDA device records in Amherst, NY. FDA records list 11 510(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
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Ivoclar USA, Inc. between 1984 and 2001. The busiest year on record is 1987, with 4. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 1 |
| 1987 | 4 |
| 1992 | 1 |
| 1994 | 1 |
| 1998 | 2 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012877 | HIGH GOLD PALLADIUM FREE CERAMIC SOLDER | EJT | Substantially Equivalent | |
| K981264 | ARISTON PHC | EBF | Substantially Equivalent | |
| K980986 | PROCAD | EIH | Substantially Equivalent | |
| K941849 | PROVIPONT C&B | EBG | Substantially Equivalent | |
| K923644 | DW243-64 | EJS | Substantially Equivalent | |
| K864708 | SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN | EBI | Substantially Equivalent | |
| K864710 | ISOSIT N | EBF | Substantially Equivalent | |
| K864709 | IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL | EBI | Substantially Equivalent | |
| K864707 | SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH | ELM | Substantially Equivalent | |
| K863421 | SR-IVOLEN TRAY MATERIAL | EBH | Substantially Equivalent | |
| K844349 | SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS | ELM | 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