Data / Medical devices / United States / Dentsply LLC
Dentsply LLC: FDA-registered device maker in York, PA, United States, 48 510(k) clearances
Dentsply LLC is registered with the FDA (registration 2424472) in York, PA, United States. It lists 41 device types. The FDA files 48 510(k) clearances under its listings, the newest dated December 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2424472
- FEI number
- 3002088145
- Address
- 1301 Smile Way, York, PA, United States, 17404
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 28, 1977
- Registered through
- 2026
- Brand names listed
- Adhesive Bite-Wing Tabs, Adhesive Comfort Tab for Film -Cover Cozee®, Aquasil Ultra Cordless digit Power Dispenser, BAI Bite-Block film holders, BAI Instrument Kits, Bite-Wing Bite-Blocks film holders, Bite-Wing Instrument Kits, Bite-Wing Loops film holders and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 17, 2024 | K243336 | Lucitone Digital Print Denture System | EBI | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| October 20, 2023 | K231578 | Lucitone Digital Print Denture System | EBI | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| November 1, 2019 | K183018 | VPro5 | OYH | Substantially Equivalent | Propel Orthodontics, LLC | accessdata.fda.gov |
| August 26, 2019 | K191427 | Halley resin system | EBI | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| April 24, 2019 | K190043 | Halley resin | EBI | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| December 18, 2018 | K182422 | Lucitone Denture Base Materials | EBI | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| October 6, 2016 | K161330 | Pour Acrylic | EBI | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| September 27, 2016 | K160825 | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology | EKX | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| August 12, 2016 | K161269 | CELTRA Press | EIH | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| June 7, 2016 | K160232 | Disposable Barrier Sleeves and Covers | PEM | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| June 16, 2015 | K150535 | Cavitron Touch Ultrasonic Scaling System | ELC | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| July 23, 2013 | K130862 | CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM | ELC | Substantially Equivalent | Dentsply Intl., Inc. | accessdata.fda.gov |
| October 15, 2012 | K122331 | CAVITY VARNISH | LBH | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| August 6, 2012 | K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | EJR | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| April 20, 2011 | K110768 | COMPUTED DENTAL RADIOGRAPHY | MUH | Substantially Equivalent | Schick Technologies, Inc. | accessdata.fda.gov |
| November 30, 2009 | K093453 | MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM | EAP | Substantially Equivalent | Schick Technologies, Inc. | accessdata.fda.gov |
| August 28, 2009 | K091706 | QUATTRO PORCELAIN SYSTEM | EIH | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| November 2, 2007 | K072134 | SCHICK COMPUTED ORAL RADIOLOGY SYSTEM | MUH | Substantially Equivalent | Schick Technologies, Inc. | accessdata.fda.gov |
| August 14, 2006 | K061716 | PRESTIGE AMERITECH FACE MASK | FXX | Substantially Equivalent | Prestige Ameritech | accessdata.fda.gov |
| September 2, 2005 | K052334 | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 | ELC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| December 4, 2003 | K033705 | BOBCAT PRO SCALER SYSTEM, MODEL G-130 | ELC | Substantially Equivalent | Dentsply International | accessdata.fda.gov |
| April 14, 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | EGS | Substantially Equivalent | Pac-Dent International (Suzhou), Ltd. | accessdata.fda.gov |
| February 7, 2003 | K030111 | DIAMONDCOAT ULTRASONIC INSERTS | ELC | Substantially Equivalent | Dentsply International | accessdata.fda.gov |
| November 6, 2002 | K023697 | STERI-MATE STERILIZABLE HANDPIECE | ELC | Substantially Equivalent | Dentsply International | accessdata.fda.gov |
| May 7, 2002 | K020612 | SULTAN SPOROX TEST VIAL, MODEL 75195 | JOJ | Substantially Equivalent | Sultan Chemists, Inc. | accessdata.fda.gov |
| March 15, 2002 | K014188 | NEW PROPHY POWDER | KOJ | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| August 20, 1999 | K991909 | DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT | EBC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| March 30, 1999 | K990703 | SPOROX II STERILIZING & DISINFECTING SOLUTION | MED | Substantially Equivalent | Reckitt Benckiser, Inc. | accessdata.fda.gov |
| March 15, 1999 | K984427 | EXCELSIOR PORCELAIN SYSTEM | EIH | Substantially Equivalent | Ney Dental, Inc. | accessdata.fda.gov |
| April 11, 1997 | K970123 | DENTSPLY CAVITRON SPS SCALER SYSTEM | ELC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| April 4, 1997 | K970342 | CAVITRON JET WITH SPS SYSTEM | ELC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| May 3, 1995 | K951296 | DELTON F PIT & FISSURE SEALANT | EBC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| June 10, 1994 | K942031 | CAULK TOOTH CONDITIONER GEL AND SYRINGE | EBF | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| March 1, 1994 | K940252 | FINESSE PORCELAIN SYSTEM | EIH | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| January 31, 1994 | K933455 | COMPUTED ORAL RADIOLOGY SYSTEM | EAP | Substantially Equivalent | Schick Technologies, Inc. | accessdata.fda.gov |
| July 26, 1993 | K932134 | RINN UNIVERSAL COLLIMATOR | IZX | Substantially Equivalent | Rinn Corp. | accessdata.fda.gov |
| May 3, 1992 | K920499 | SANI-TIP | ECB | Substantially Equivalent | Dw Industries, Inc. | accessdata.fda.gov |
| April 28, 1992 | K920758 | JENKER NEEDLE STICK PROTECTOR | DZM | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| April 16, 1991 | K903298 | DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP | ELC | Substantially Equivalent | Micro Motors, Inc. | accessdata.fda.gov |
| October 10, 1990 | K903163 | PERIODONTAL DEBRIDING SOLUTION E | ELC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| August 13, 1990 | K902413 | SONIC SCALER | ELC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| April 16, 1990 | K900393 | OPAQUE PORCELAIN | EIH | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| February 19, 1987 | K864996 | ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 | ELC | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| July 26, 1984 | K842392 | DELTON * OPAQUE LIGHT CURING PIT | EBC | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| June 30, 1983 | K831380 | DELTON LIGHT CURING PIT & FISSURE | EBC | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| January 14, 1981 | K803310 | CERAMCO PORCELAIN | EIH | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
| December 6, 1979 | K792445 | MW STRAIGHT ATTACHMENT | EGS | Substantially Equivalent | Midwest | accessdata.fda.gov |
| August 3, 1979 | K790935 | DELTON* PIT AND FISSURE SEALENT | EBC | Substantially Equivalent | Johnson & Johnson Professionals, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Extraoral Source, Digital
- All makers of Scaler, Ultrasonic
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
- All makers of Powder, Porcelain
- All makers of Sealant, Pit And Fissure, And Conditioner
- All makers of General Purpose Dental Tray
Updated December 17, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.