Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ivoclar North America, Inc. · Predicate Candidate Screening
131 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
52 daysmedian FDA review time
129 days90th percentile
131clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012174 | ERIS LAYERING MATERIALS | Ivoclar North America, Inc. | 2001-08-27 | 46 | 1 |
| K011491 | HELIOSEAL CLEAR CHROMA | Ivoclar North America, Inc. | 2001-08-16 | 93 | 0 |
| K011492 | IN TEN-S | Ivoclar North America, Inc. | 2001-07-05 | 51 | 0 |
| K011490 | MODIFICATION TO EXCITE | Ivoclar North America, Inc. | 2001-06-27 | 43 | 0 |
| K011022 | BIOUNIVERSAL PDF | Ivoclar North America, Inc. | 2001-05-02 | 28 | 0 |
| K011023 | D.SIGN 96 | Ivoclar North America, Inc. | 2001-05-02 | 28 | 0 |
| K010381 | D.SIGN 30 | Ivoclar North America, Inc. | 2001-03-06 | 26 | 0 |
| K010250 | TETRIC CERAM HB | Ivoclar North America, Inc. | 2001-02-28 | 33 | 0 |
| K003293 | EXCITE DSC | Ivoclar North America, Inc. | 2001-02-06 | 109 | 0 |
| K003407 | SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) | Ivoclar North America, Inc. | 2001-01-26 | 86 | 0 |
| K003635 | DW 276 #3 | Ivoclar North America, Inc. | 2000-12-22 | 28 | 0 |
| K003634 | DW 272 #1 | Ivoclar North America, Inc. | 2000-12-21 | 27 | 0 |
| K003632 | DW 273 #1 | Ivoclar North America, Inc. | 2000-12-20 | 26 | 0 |
| K003633 | DW 277 #4 | Ivoclar North America, Inc. | 2000-12-20 | 26 | 0 |
| K003374 | FERMIT PLUS | Ivoclar North America, Inc. | 2000-12-04 | 35 | 0 |
| K003377 | FERMIT N PLUS | Ivoclar North America, Inc. | 2000-12-04 | 35 | 0 |
| K003373 | PROCAD ADD-ON | Ivoclar North America, Inc. | 2000-11-28 | 29 | 0 |
| K002872 | R&D PROJECT DW271#11A | Ivoclar North America, Inc. | 2000-11-02 | 49 | 0 |
| K001469 | R&D PROJECT DW269#25 | Ivoclar North America, Inc. | 2000-07-05 | 56 | 0 |
| K993783 | TETRIC FLOW | Ivoclar North America, Inc. | 1999-12-13 | 35 | 0 |
| K990817 | IPS D.SIGN PORCELAIN | Ivoclar North America, Inc. | 1999-04-06 | 26 | 0 |
| K990534 | EXCITE | Ivoclar North America, Inc. | 1999-03-19 | 28 | 0 |
| K990315 | MONOPAQUE | Ivoclar North America, Inc. | 1999-03-04 | 31 | 0 |
| K990182 | D-SIGN V (R&D PROJECT DW267#17) | Ivoclar North America, Inc. | 1999-03-01 | 40 | 0 |
| K990235 | D-SIGN VI (R&D PROJECT DW266#9) | Ivoclar North America, Inc. | 1999-03-01 | 35 | 0 |
| K990077 | D-SIGN III (R&D PROJECT DW264#7) | Ivoclar North America, Inc. | 1999-02-12 | 32 | 0 |
| K990078 | D-SIGN IV (R&D PROJECT DW265#37) | Ivoclar North America, Inc. | 1999-02-12 | 32 | 0 |
| K984451 | D-SIGN I (R&D PROJECT DW263 #24) | Ivoclar North America, Inc. | 1999-01-19 | 35 | 0 |
| K982616 | IPS EMPRESS 2 | Ivoclar North America, Inc. | 1998-09-08 | 43 | 0 |
| K981335 | ARISTON PHC LINER | Ivoclar North America, Inc. | 1998-07-02 | 80 | 0 |
| K980922 | PROTEC CEM. | Ivoclar North America, Inc. | 1998-04-30 | 50 | 0 |
| K974577 | COMPOGLASS FLOW | Ivoclar North America, Inc. | 1998-01-30 | 53 | 0 |
| K973397 | SYNTAC SPRINT | Ivoclar North America, Inc. | 1997-11-21 | 73 | 0 |
| K972648 | SONICSYS INLAY | Ivoclar North America, Inc. | 1997-10-30 | 107 | 0 |
| K972827 | IPS EMPRESS COSMO INGOT | Ivoclar North America, Inc. | 1997-09-17 | 49 | 0 |
| K972875 | COSMOPOST | Ivoclar North America, Inc. | 1997-09-17 | 44 | 0 |
| K971513 | COMPOGLASS F | Ivoclar North America, Inc. | 1997-06-03 | 36 | 0 |
| K971372 | VARIOLINK II | Ivoclar North America, Inc. | 1997-05-29 | 45 | 0 |
| K970963 | TARGIS ALLOY #7 | Ivoclar North America, Inc. | 1997-04-30 | 44 | 0 |
| K964285 | TETRIC CERAM | Ivoclar North America, Inc. | 1997-01-22 | 86 | 0 |
| K964772 | AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) | Ivoclar North America, Inc. | 1997-01-17 | 51 | 0 |
| K962878 | TARGIS SYSTEM | Ivoclar North America, Inc. | 1996-09-25 | 63 | 0 |
| K962456 | SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH | Ivoclar North America, Inc. | 1996-08-06 | 42 | 0 |
| K961910 | VIVAGLASS FIL | Ivoclar North America, Inc. | 1996-06-26 | 40 | 0 |
| K962297 | VIVAGLASS CEM | Ivoclar North America, Inc. | 1996-06-26 | 40 | 0 |
| K954837 | DW260 19 | Ivoclar North America, Inc. | 1995-11-15 | 26 | 0 |
| K951836 | COMPOLGLASS COMPOGLASS SCA | Ivoclar North America, Inc. | 1995-05-25 | 35 | 0 |
| K951297 | HARMONY LINE KF | Ivoclar North America, Inc. | 1995-04-18 | 27 | 0 |
| K951298 | MAXIGOLD KF | Ivoclar North America, Inc. | 1995-04-18 | 27 | 0 |
| K950517 | HARMONY LINE PF | Ivoclar North America, Inc. | 1995-03-23 | 45 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda