Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentsply Intl. — Predicate Candidate Screening
279 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
125 days90th percentile
279clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC | Dentsply Intl. | 2013-02-22 | 91 | 0 |
| K072730 | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS | Dentsply Intl. | 2008-03-27 | 183 | 0 |
| K070538 | XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE | Dentsply Intl. | 2007-03-14 | 16 | 0 |
| K070019 | CARRARA VOLUMIA | Dentsply Intl. | 2007-01-26 | 23 | 0 |
| K061427 | PRE-IMPRESSION CONDITIONING SOLUTION | Dentsply Intl. | 2006-06-26 | 34 | 0 |
| K052334 | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIEC | Dentsply Intl. | 2005-09-02 | 7 | 0 |
| K051707 | ECLIPSE BONDING AGENT | Dentsply Intl. | 2005-07-15 | 18 | 0 |
| K051463 | XENO ADHESIVE WITH ACTIVATOR | Dentsply Intl. | 2005-07-12 | 39 | 0 |
| K051462 | MODIFICATION TO: CERCON BASE | Dentsply Intl. | 2005-06-24 | 21 | 0 |
| K050880 | DYRACT EXTRA RESTORATIVE | Dentsply Intl. | 2005-04-22 | 16 | 0 |
| K050750 | LC BRACKET ADHESIVE SYSTEM | Dentsply Intl. | 2005-04-06 | 14 | 0 |
| K043247 | DUCERA ALLCERAM | Dentsply Intl. | 2004-12-22 | 29 | 0 |
| K042905 | NEO-CLIP ORTHODONTIC BRACKET ACCESSORY | Dentsply Intl. | 2004-11-04 | 14 | 0 |
| K041272 | DYRACT CEM PLUS CEMENT | Dentsply Intl. | 2004-10-18 | 159 | 0 |
| K042178 | ORTHODONTIC CERAMIC BRACKETS | Dentsply Intl. | 2004-08-30 | 19 | 0 |
| K041707 | CERCON CERAM EXPRESS CERAMIC SYSTEM | Dentsply Intl. | 2004-07-30 | 37 | 0 |
| K040906 | CALIBRA CEMENT | Dentsply Intl. | 2004-06-16 | 70 | 0 |
| K041141 | DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, | Dentsply Intl. | 2004-06-16 | 47 | 0 |
| K040895 | INTEGRITY TEMPORARY CEMENT | Dentsply Intl. | 2004-05-21 | 45 | 0 |
| K040375 | IDEAL 1 ORTHODONTIC BAND CEMENT | Dentsply Intl. | 2004-04-02 | 45 | 0 |
| K040635 | CARRARA INTERACTION CERAMIC SYSTEM | Dentsply Intl. | 2004-03-30 | 20 | 0 |
| K040421 | DUCERAGOLD PORCELAINS | Dentsply Intl. | 2004-03-18 | 29 | 0 |
| K040420 | DUCERAM PLUS CERAMIC SYSTEM | Dentsply Intl. | 2004-03-18 | 29 | 0 |
| K033703 | IDEAL 1 ORTHODONTIC BRACKET ADHESIVE | Dentsply Intl. | 2004-02-06 | 73 | 0 |
| K033667 | CARRARA PRESS SYSTEM | Dentsply Intl. | 2004-01-23 | 63 | 0 |
| K032361 | ENDOPURE ROOT CANAL CLEANSER | Dentsply Intl. | 2004-01-12 | 165 | 0 |
| K033553 | PFZ PORCELAIN SYSTEM | Dentsply Intl. | 2003-12-02 | 22 | 0 |
| K032904 | ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 | Dentsply Intl. | 2003-10-14 | 27 | 0 |
| K024133 | CLS-2000 UNIT | Dentsply Intl. | 2003-10-01 | 289 | 0 |
| K032317 | ORION GX ALLOY | Dentsply Intl. | 2003-09-30 | 64 | 0 |
| K032316 | ORION E ALLOY | Dentsply Intl. | 2003-09-30 | 64 | 0 |
| K032892 | MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM | Dentsply Intl. | 2003-09-26 | 9 | 0 |
| K031932 | FLUORIDE VARNISH | Dentsply Intl. | 2003-09-15 | 84 | 0 |
| K031461 | CARRIER TIPS | Dentsply Intl. | 2003-08-05 | 89 | 0 |
| K031145 | ESTYLUS ELECTRIC MOTOR SYSTEM | Dentsply Intl. | 2003-07-15 | 96 | 0 |
| K023776 | XENO III DENTAL ADHESIVE | Dentsply Intl. | 2003-01-23 | 72 | 0 |
| K022796 | CERCON CERAM S PORCELAIN | Dentsply Intl. | 2002-09-06 | 14 | 0 |
| K021805 | SEAL & PROTECT PROTECTIVE SEALANT | Dentsply Intl. | 2002-08-19 | 77 | 0 |
| K021416 | AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MA | Dentsply Intl. | 2002-05-13 | 10 | 0 |
| K021413 | AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL | Dentsply Intl. | 2002-05-10 | 7 | 0 |
| K021410 | AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL | Dentsply Intl. | 2002-05-08 | 5 | 0 |
| K014188 | NEW PROPHY POWDER | Dentsply Intl. | 2002-03-15 | 84 | 0 |
| K012720 | TULSA CONTRA ANGLES | Dentsply Intl. | 2001-11-08 | 85 | 0 |
| K011560 | TRUBYTE DENTURE BASE RESIN SYSTEM | Dentsply Intl. | 2001-07-12 | 52 | 0 |
| K003921 | DYRACT CEM LCI COMPOMER | Dentsply Intl. | 2001-01-24 | 35 | 0 |
| K003518 | RAPIDD HIGHSPEED DENTAL HANDPIECE | Dentsply Intl. | 2001-01-09 | 55 | 0 |
| K002387 | COMFORT CONTROL SYRINGE SYSTEM | Dentsply Intl. | 2000-09-28 | 55 | 0 |
| K000996 | TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND | Dentsply Intl. | 2000-06-16 | 80 | 0 |
| K000112 | ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1 | Dentsply Intl. | 2000-04-13 | 90 | 0 |
| K000169 | NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN | Dentsply Intl. | 2000-03-24 | 64 | 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