Dentsply International, Inc.
York, PA, US
Dentsply International, Inc. appears in FDA device records in York, PA. FDA records list 59 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 59
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 59FDA records hold 59 510(k) clearances for Dentsply International, Inc. between 2001 and 2016. The busiest year on record is 2003, with 8. The most recent is 2016, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 8 |
| 2004 | 4 |
| 2005 | 5 |
| 2006 | 5 |
| 2007 | 8 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 4 |
| 2013 | 3 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K160207 | ATLANTIS ISUS Implant Suprastructures | NHA | Substantially Equivalent | |
| K160232 | Disposable Barrier Sleeves and Covers | PEM | Substantially Equivalent | |
| K151439 | ATLANTIS ISUS | NHA | Substantially Equivalent | |
| K152247 | ATLANTIS Crown | EIH | Substantially Equivalent | |
| K151039 | ATLANTIS Abutment for NobelActive 3.0 | NHA | Substantially Equivalent | |
| K151619 | Prime&Bond Elect Universal Dental Adhesive | KLE | Substantially Equivalent | |
| K150535 | Cavitron Touch Ultrasonic Scaling System | ELC | Substantially Equivalent | |
| K142178 | PROROOT MTA WHITE, PROROOT MTA GRAY | KIF | Substantially Equivalent | |
| K131907 | RAYPEX 6 | LQY | Substantially Equivalent | |
| K131644 | ANKYLOS SYNCONE ABUTMENT 5(DEGREE) | NHA | Substantially Equivalent | |
| K132145 | MTM(R) CLEAR ALIGNER | NXC | Substantially Equivalent | |
| K122424 | ISUS IMPLANT SUPRASTRUCTURES | NHA | Substantially Equivalent | |
| K123925 | MTM CLEAR ALIGNER IN-OFFICE | NXC | Substantially Equivalent | |
| K122268 | ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS | NHA | Substantially Equivalent | |
| K122331 | CAVITY VARNISH | LBH | Substantially Equivalent | |
| K121698 | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | EJR | Substantially Equivalent | |
| K113406 | AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL | ELW | Substantially Equivalent | |
| K112152 | CERCON HT | EIH | Substantially Equivalent | |
| K110753 | MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM | EKX | Substantially Equivalent | |
| K103653 | E3 TORQUE CONTROL MOTOR | EBW | Substantially Equivalent | |
| K101493 | ADVANCED GLASS IONOMER (K-130) RESTORATIVE | EMA | Substantially Equivalent | |
| K091706 | QUATTRO PORCELAIN SYSTEM | EIH | Substantially Equivalent | |
| K083841 | ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL | EBF | Substantially Equivalent | |
| K083326 | FLUOROCORE 2 | EBF | Substantially Equivalent | |
| K073075 | FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS | DZE | Substantially Equivalent | |
| K073067 | ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS | DZE | Substantially Equivalent | |
| K073073 | ANKYLOS TEMPORARY ABUTMENT BALANCE | NHA | Substantially Equivalent | |
| K072522 | THERMOFORM SHEET MATERIALS AND ACCESSORIES | MQC | Substantially Equivalent | |
| K072713 | ION DENTAL RESIN SYSTEM | EBI | Substantially Equivalent | |
| K072342 | SULTAN TOOTH ROOT DESENSITIZER | LBH | Substantially Equivalent | |
| K072052 | OSTEOGRAF/D-300 | LYC | Substantially Equivalent | |
| K072057 | OSTEOGRAF/LD-300 | LYC | Substantially Equivalent | |
| K072056 | OSTEOGRAF/D-700 | LYC | Substantially Equivalent | |
| K070307 | STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT | ELC | Substantially Equivalent | |
| K070306 | PAINT- ON POLISH AGENT | EBD | Substantially Equivalent | |
| K061580 | ECLIPSE WAX REMOVER | EBI | Substantially Equivalent | |
| K061264 | TEMPFX ESTHETIC PROVISIONAL SYSTEM | EBG | Substantially Equivalent | |
| K060837 | IN-OVATION C | NJM | Substantially Equivalent | |
| K053368 | INTERPROXIMAL REDUCTION SYSTEM | EFB | Substantially Equivalent | |
| K060293 | TEMPORARY CROWN AND BRIDGE MATERIAL | EBG | Substantially Equivalent | |
| K052370 | CP BRACKET SYSTEM | DYW | Substantially Equivalent | |
| K052097 | CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE | EBF | Substantially Equivalent | |
| K050208 | FRIADENT ESTHETICAP | NHA | Substantially Equivalent | |
| K050959 | DELTON ILLUMINATING PIT AND FISSURE SEALING | EBC | Substantially Equivalent | |
| K050386 | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM | KLE | Substantially Equivalent | |
| K041372 | SMARTLITE PS PEN-STYLE LED CURING LIGHT | EBZ | Substantially Equivalent | |
| K041343 | XENO NM LIGHT CURED DENTAL ADHESIVE | KLE | Substantially Equivalent | |
| K041335 | PTM SYSTEM | EIH | Substantially Equivalent | |
| K040144 | QUIXX POSTERIOR RESTORATIVE | EBF | Substantially Equivalent | |
| K033705 | BOBCAT PRO SCALER SYSTEM, MODEL G-130 | ELC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- EBZActivator, Ultraviolet, For Polymerization
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- NXCAligner, Sequential
- EJTAlloy, Gold-Based Noble Metal
- LYCBone Grafting Material, Synthetic
- NJMBracket, Ceramic, Orthodontic
- DYWBracket, Plastic, Orthodontic
- EMACement, Dental
- EBDCoating, Filling Material, Resin
- EBWController, Foot, Handpiece And Cord
- EBGCrown And Bridge, Temporary, Resin
- PEMDental Barriers And Sleeves
- EFBHandpiece, Air-Powered, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- DZEImplant, Endosseous, Root-Form
- LQYLocator, Root Apex
- ELWMaterial, Impression
- EBFMaterial, Tooth Shade, Resin
- MQCMouthguard, Prescription
- EIHPowder, Porcelain
- EBIResin, Denture, Relining, Repairing, Rebasing
- KIFResin, Root Canal Filling
- ELCScaler, Ultrasonic
- EBCSealant, Pit And Fissure, And Conditioner
- LBHVarnish, Cavity
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain