Company ยท US
Ivoclar North America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2001. Name variants (Inc, Corp, punctuation) are merged.
131510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | 29 |
| EBF | Material, Tooth Shade, Resin | 28 |
| EJS | Alloy, Other Noble Metal | 12 |
| EIH | Powder, Porcelain | 10 |
| EMA | Cement, Dental | 9 |
| KLE | Agent, Tooth Bonding, Resin | 5 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 4 |
| EJH | Alloy, Metal, Base | 4 |
| EJJ | Alloy, Amalgam | 4 |
| EBG | Crown And Bridge, Temporary, Resin | 3 |
| EBZ | Activator, Ultraviolet, For Polymerization | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 |
| EFD | Amalgamator, Dental, Ac-Powered | 2 |
| EJK | Liner, Cavity, Calcium Hydroxide | 2 |
| ELL | Teeth, Porcelain | 2 |
| ELR | Post, Root Canal | 2 |
| LBH | Varnish, Cavity | 2 |
| DZA | Drill, Dental, Intraoral | 1 |
| DZN | Instruments, Dental Hand | 1 |
| EHY | Tray, Impression, Preformed | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2001 | K012174 | ERIS LAYERING MATERIALS Ivoclar North America, Inc. | EIH |
| Aug 16, 2001 | K011491 | HELIOSEAL CLEAR CHROMA Ivoclar North America, Inc. | EBC |
| Jul 5, 2001 | K011492 | IN TEN-S Ivoclar North America, Inc. | EBF |
| Jun 27, 2001 | K011490 | MODIFICATION TO EXCITE Ivoclar North America, Inc. | KLE |
| May 2, 2001 | K011023 | D.SIGN 96 Ivoclar North America, Inc. | EJT |
| May 2, 2001 | K011022 | BIOUNIVERSAL PDF Ivoclar North America, Inc. | EJT |
| Mar 6, 2001 | K010381 | D.SIGN 30 Ivoclar North America, Inc. | EJH |
| Feb 28, 2001 | K010250 | TETRIC CERAM HB Ivoclar North America, Inc. | EBF |
| Feb 6, 2001 | K003293 | EXCITE DSC Ivoclar North America, Inc. | KLE |
| Jan 26, 2001 | K003407 | SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) Ivoclar North America, Inc. | EMA |
| Dec 22, 2000 | K003635 | DW 276 #3 Ivoclar North America, Inc. | EJT |
| Dec 21, 2000 | K003634 | DW 272 #1 Ivoclar North America, Inc. | EJT |
| Dec 20, 2000 | K003633 | DW 277 #4 Ivoclar North America, Inc. | EJT |
| Dec 20, 2000 | K003632 | DW 273 #1 Ivoclar North America, Inc. | EJS |
| Dec 4, 2000 | K003377 | FERMIT N PLUS Ivoclar North America, Inc. | EBG |
| Dec 4, 2000 | K003374 | FERMIT PLUS Ivoclar North America, Inc. | EBG |
| Nov 28, 2000 | K003373 | PROCAD ADD-ON Ivoclar North America, Inc. | EIH |
| Nov 2, 2000 | K002872 | R&D PROJECT DW271#11A Ivoclar North America, Inc. | EJT |
| Jul 5, 2000 | K001469 | R&D PROJECT DW269#25 Ivoclar North America, Inc. | EJS |
| Dec 13, 1999 | K993783 | TETRIC FLOW Ivoclar North America, Inc. | EBF |
| Apr 6, 1999 | K990817 | IPS D.SIGN PORCELAIN Ivoclar North America, Inc. | EIH |
| Mar 19, 1999 | K990534 | EXCITE Ivoclar North America, Inc. | KLE |
| Mar 4, 1999 | K990315 | MONOPAQUE Ivoclar North America, Inc. | EBF |
| Mar 1, 1999 | K990235 | D-SIGN VI (R&D PROJECT DW266#9) Ivoclar North America, Inc. | EJH |
| Mar 1, 1999 | K990182 | D-SIGN V (R&D PROJECT DW267#17) Ivoclar North America, Inc. | EJH |
| Feb 12, 1999 | K990078 | D-SIGN IV (R&D PROJECT DW265#37) Ivoclar North America, Inc. | EJS |
| Feb 12, 1999 | K990077 | D-SIGN III (R&D PROJECT DW264#7) Ivoclar North America, Inc. | EJS |
| Jan 19, 1999 | K984451 | D-SIGN I (R&D PROJECT DW263 #24) Ivoclar North America, Inc. | EJS |
| Sep 8, 1998 | K982616 | IPS EMPRESS 2 Ivoclar North America, Inc. | EIH |
| Jul 2, 1998 | K981335 | ARISTON PHC LINER Ivoclar North America, Inc. | EMA |
| Apr 30, 1998 | K980922 | PROTEC CEM. Ivoclar North America, Inc. | EMA |
| Jan 30, 1998 | K974577 | COMPOGLASS FLOW Ivoclar North America, Inc. | EBF |
| Nov 21, 1997 | K973397 | SYNTAC SPRINT Ivoclar North America, Inc. | EMA |
| Oct 30, 1997 | K972648 | SONICSYS INLAY Ivoclar North America, Inc. | EIH |
| Sep 17, 1997 | K972875 | COSMOPOST Ivoclar North America, Inc. | ELR |
| Sep 17, 1997 | K972827 | IPS EMPRESS COSMO INGOT Ivoclar North America, Inc. | EIH |
| Jun 3, 1997 | K971513 | COMPOGLASS F Ivoclar North America, Inc. | EBF |
| May 29, 1997 | K971372 | VARIOLINK II Ivoclar North America, Inc. | EBF |
| Apr 30, 1997 | K970963 | TARGIS ALLOY #7 Ivoclar North America, Inc. | EJT |
| Jan 22, 1997 | K964285 | TETRIC CERAM Ivoclar North America, Inc. | EBF |
| Jan 17, 1997 | K964772 | AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) Ivoclar North America, Inc. | EJT |
| Sep 25, 1996 | K962878 | TARGIS SYSTEM Ivoclar North America, Inc. | EBF |
| Aug 6, 1996 | K962456 | SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH Ivoclar North America, Inc. | ELM |
| Jun 26, 1996 | K962297 | VIVAGLASS CEM Ivoclar North America, Inc. | EMA |
| Jun 26, 1996 | K961910 | VIVAGLASS FIL Ivoclar North America, Inc. | EMA |
| Nov 15, 1995 | K954837 | DW260 19 Ivoclar North America, Inc. | EJT |
| May 25, 1995 | K951836 | COMPOLGLASS COMPOGLASS SCA Ivoclar North America, Inc. | EBF |
| Apr 18, 1995 | K951298 | MAXIGOLD KF Ivoclar North America, Inc. | EJT |
| Apr 18, 1995 | K951297 | HARMONY LINE KF Ivoclar North America, Inc. | EJT |
| Mar 23, 1995 | K950517 | HARMONY LINE PF Ivoclar North America, Inc. | EJT |
Newest 50 of 131.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||