Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sirona Dental Systems GmbH · Predicate Candidate Screening
42 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
198 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160099 | CEREC SpeedGlaze | Sirona Dental Systems GmbH | 2016-06-02 | 135 | 0 |
| K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | 2015-07-24 | 95 | 0 |
| K150909 | INTEGO Family and Accesories | Sirona Dental Systems GmbH | 2015-07-17 | 105 | 0 |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | 2015-07-02 | 101 | 0 |
| K150217 | ORTHOPHOS SL | Sirona Dental Systems GmbH | 2015-05-08 | 98 | 0 |
| K131319 | T1/T2/T3 TURBINE FAMILY | Sirona Dental Systems GmbH | 2014-05-30 | 388 | 0 |
| K132773 | SIDEXIS 4 | Sirona Dental Systems GmbH | 2013-12-11 | 97 | 0 |
| K123664 | INCORIS ZI | Sirona Dental Systems GmbH | 2013-04-08 | 131 | 0 |
| K123952 | CEREC BLOCS C IN | Sirona Dental Systems GmbH | 2013-03-20 | 89 | 0 |
| K123070 | GALILEOS FAMILY | Sirona Dental Systems GmbH | 2013-03-15 | 165 | 0 |
| K123545 | INCORIS TZI | Sirona Dental Systems GmbH | 2013-02-01 | 74 | 0 |
| K111421 | SIRONA DENTAL CAD/CAM SYSTEM | Sirona Dental Systems GmbH | 2012-02-17 | 273 | 0 |
| K103711 | ORTHOPHOS XG 3D / CEPH | Sirona Dental Systems GmbH | 2011-03-22 | 92 | 0 |
| K103753 | SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED | Sirona Dental Systems GmbH | 2011-02-15 | 54 | 0 |
| K100152 | SIRONA CAD/CAM SYSTEM | Sirona Dental Systems GmbH | 2010-10-22 | 276 | 0 |
| K092660 | SIROLASER ADVANCE | Sirona Dental Systems GmbH | 2009-12-03 | 97 | 0 |
| K083344 | HELIODENT PLUS | Sirona Dental Systems GmbH | 2008-12-23 | 40 | 0 |
| K081903 | XIOS PLUS WALL-MODULE | Sirona Dental Systems GmbH | 2008-08-26 | 54 | 0 |
| K080882 | CEREC OPTI SPRAY | Sirona Dental Systems GmbH | 2008-04-11 | 11 | 0 |
| K072107 | PERIOSCAN, MODEL: D 3496 | Sirona Dental Systems GmbH | 2008-02-14 | 198 | 0 |
| K062509 | INCORIS ZI | Sirona Dental Systems GmbH | 2006-09-12 | 15 | 0 |
| K062506 | INCORIS AL | Sirona Dental Systems GmbH | 2006-09-08 | 11 | 0 |
| K060892 | GALILEOS | Sirona Dental Systems GmbH | 2006-04-14 | 11 | 0 |
| K052515 | SIROENDO | Sirona Dental Systems GmbH | 2006-03-31 | 198 | 0 |
| K053161 | SIROLASER | Sirona Dental Systems GmbH | 2006-01-18 | 65 | 0 |
| K051661 | IMPLANT HANDPIECES | Sirona Dental Systems GmbH | 2005-09-06 | 76 | 0 |
| K050354 | PERIOSCAN ULTRASONIC SCALER | Sirona Dental Systems GmbH | 2005-03-21 | 35 | 0 |
| K033812 | SIROAIR L AIR SCALER | Sirona Dental Systems GmbH | 2004-02-23 | 76 | 0 |
| K033675 | PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER | Sirona Dental Systems GmbH | 2004-01-15 | 52 | 0 |
| K033640 | SIROSON L AND SIROSONIC L ULTRASONIC SCALERS | Sirona Dental Systems GmbH | 2003-12-12 | 22 | 0 |
| K032543 | SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSOR | Sirona Dental Systems GmbH | 2003-11-14 | 88 | 0 |
| K033073 | ORTHOPHOS XG DS/CEPH | Sirona Dental Systems GmbH | 2003-10-10 | 11 | 0 |
| K031584 | SIROTORQUE L | Sirona Dental Systems GmbH | 2003-08-19 | 90 | 0 |
| K013650 | ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD | Sirona Dental Systems GmbH | 2001-12-06 | 30 | 0 |
| K013659 | MODIFICATION TO SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM | Sirona Dental Systems GmbH | 2001-12-06 | 30 | 0 |
| K012517 | CEREC3 VITABLOCKS | Sirona Dental Systems GmbH | 2001-11-01 | 87 | 0 |
| K000672 | HELIODENT VARIO | Sirona Dental Systems GmbH | 2000-05-02 | 64 | 0 |
| K994172 | CEREC 3 | Sirona Dental Systems GmbH | 2000-02-08 | 60 | 0 |
| K992644 | SIDEXIS DIGITAL RADIOGRAPHY IMAGING SYSTEM | Sirona Dental Systems GmbH | 1999-08-23 | 17 | 0 |
| K990528 | ORTHOPHOS 3/3 CEPH/3 DS | Sirona Dental Systems GmbH | 1999-04-30 | 70 | 0 |
| K983242 | SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES | Sirona Dental Systems GmbH | 1998-12-11 | 86 | 0 |
| K983057 | ORTHOPHOS 5/PLUS/CD | Sirona Dental Systems GmbH | 1998-10-22 | 51 | 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