Company ยท US
Coltene/Whaledent, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2019. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (0 in 12 months)
15recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 10 |
| EMA | Cement, Dental | 9 |
| EJL | Bur, Dental | 7 |
| EJG | Forceps, Rubber Dam Clamp | 4 |
| ELR | Post, Root Canal | 4 |
| KLE | Agent, Tooth Bonding, Resin | 4 |
| EBZ | Activator, Ultraviolet, For Polymerization | 3 |
| ELW | Material, Impression | 3 |
| ELC | Scaler, Ultrasonic | 2 |
| FRG | Wrap, Sterilization | 2 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 |
| EIE | Dam, Rubber | 1 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 1 |
| KIF | Resin, Root Canal Filling | 1 |
| KMH | Sterilizer, Dry Heat | 1 |
| MVL | Cord, Retraction | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2019 | K191385 | BRILLIANT COMPONEER Coltene/Whaledent AG, CH | EBF |
| Jun 21, 2019 | K190597 | BRILLIANT EverGlow Flow Coltene/Whaledent AG, CH | EBF |
| Aug 15, 2018 | K181500 | BRILLIANT Crios Coltene/Whaledent AG, CH | EBF |
| Nov 16, 2016 | K160800 | DuoCem Coltene/Whaledent AG, CH | EMA |
| Apr 28, 2016 | K152927 | BRILLIANT EVERGLOW Coltene/Whaledent AG, CH | EBF |
| Dec 9, 2015 | K152243 | One Coat 7 Universal Coltene/Whaledent AG, CH | KLE |
| Jun 23, 2015 | K150218 | Fill-Up! Coltene/Whaledent AG, CH | EBF |
| Aug 23, 2013 | K130137 | BIOSONIC SUVI PIEZEOELECTRIC SCALER AND POLISHER Coltene/Whaledent | ELC |
| Jan 8, 2013 | K121621 | SOLOCEM Coltene/Whaledent AG, CH | EMA |
| Nov 21, 2011 | K112168 | COMPONEER Coltene/Whaledent AG | EBF |
| Feb 6, 2009 | K083304 | TEMPOSIL 2 Coltene/Whaledent AG | EMA |
| Nov 16, 2007 | K072604 | DUO TEMP Coltene/Whaledent AG | EMA |
| Oct 18, 2007 | K071632 | PERFECT TISSUE CONTOURING SYSTEM II Coltene/Whaledent, Inc. | EKZ |
| Jan 9, 2006 | K052820 | PARAPOST PARACORE AUTOMIX 5ML Coltene/Whaledent AG | EBF |
| Nov 9, 2005 | K053040 | PARACEM UNIVERSAL DC Coltene/Whaledent AG | EMA |
| Aug 4, 2005 | K051660 | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM Coltene/Whaledent, Inc. | KMH |
| Jun 23, 2005 | K051243 | JET BLUE BITE Coltene/Whaledent AG | ELW |
| Mar 18, 2005 | K050426 | TEMPOSIL, MODEL 6720 Coltene/Whaledent AG | EMA |
| Feb 9, 2005 | K050013 | RETRACTOFOAM Coltene/Whaledent AG | ELW |
| Jun 15, 2004 | K041023 | STAY-PUT IMPREGNATED Coltene/Whaledent GmbH & Co. KG | MVL |
| Mar 15, 2004 | K040551 | COLTOLUX LED CURING LIGHT Coltene/Whaledent, Inc. | EBZ |
| Jan 23, 2004 | K033760 | ONE COAT SE BOND Coltene/Whaledent, Inc. | KLE |
| Nov 3, 2003 | K032662 | GUTTAFLOW Coltene/Whaledent GmbH & Co. KG | KIF |
| Aug 5, 2003 | K031752 | COLTOSOL F Coltene/Whaledent, Inc. | EMA |
| Dec 10, 2001 | K013400 | SYNERGY FLOW Coltene/Whaledent, Inc. | EBF |
| Nov 30, 2000 | K003034 | COLTENE AURA COMPOMER RESTORATIVE SYSTEM Coltene/Whaledent, Inc. | EBF |
| Apr 14, 2000 | K993545 | TENAX WHITE POST Coltene/Whaledent, Inc. | ELR |
| Mar 14, 2000 | K000311 | PARAPOST FIBER WHITE Coltene/Whaledent, Inc. | ELR |
| Dec 21, 1999 | K993710 | MODIFICATION OF PARAPOST CEMENT Coltene/Whaledent, Inc. | EMA |
| Dec 16, 1999 | K993835 | PARAPOST SYSTEM STERILIZABLE ORGANIZER Coltene/Whaledent, Inc. | FRG |
| Dec 6, 1999 | K993255 | BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE Coltene/Whaledent, Inc. | FRG |
| Jan 20, 1999 | K983727 | BIOSONIC ULTRASONIC SCALER SYSTEM Coltene/Whaledent, Inc. | ELC |
| Mar 24, 1998 | K974906 | ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM Coltene/Whaledent, Inc. | KLE |
| Mar 9, 1998 | K974465 | SYNERGY Coltene/Whaledent, Inc. | EBF |
| May 24, 1995 | K950106 | COLTOLUX LIGHT METER Coltene/Whaledent, Inc. | EBZ |
| May 24, 1995 | K945698 | COLTOLUX 3, COLTOLUX 4 Coltene/Whaledent, Inc. | EBZ |
| Feb 2, 1995 | K945366 | PARAPOST CEMENT Coltene/Whaledent, Inc. | EMA |
| Jun 6, 1994 | K934192 | PARAPOST XT SYSTEM Coltene/Whaledent, Inc. | ELR |
| Aug 3, 1992 | K922615 | COLTENE A.R.T. BOND Coltene/Whaledent, Inc. | KLE |
| Jul 25, 1991 | K912485 | COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC Coltene/Whaledent, Inc. | ELW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2023 | Coltene Whaledent Inc SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing Open, Classified |
EFB | K071891 |
| Mar 18, 2021 | Coltene Whaledent Inc Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the ti Open, Classified |
EBL | None listed |
| Oct 20, 2020 | Coltene Whaledent Inc Strauss 25 Carbide
Dental Burs
(100057XXV) Open, Classified |
EJL | None listed |
| Oct 20, 2020 | Coltene Whaledent Inc CEI Cutting Edge
Instruments (PTC-57C) Open, Classified |
EJL | None listed |
| Oct 20, 2020 | Coltene Whaledent Inc Clinic Pack 100
Pieces FG 57
100057C (100057C) Open, Classified |
EJL | None listed |
| Oct 20, 2020 | Coltene Whaledent Inc FG 57 100057X (100057X) Open, Classified |
EJL | None listed |
| Oct 20, 2020 | Coltene Whaledent Inc Alpen Clinic 100 Carbide Instruments (R100057C) Open, Classified |
EJL | None listed |
| Jun 3, 2020 | Coltene Whaledent Inc HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used Open, Classified |
EJG | None listed |
| Jun 3, 2020 | Coltene Whaledent Inc HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to Open, Classified |
EJG | None listed |
| Jun 3, 2020 | Coltene Whaledent Inc HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to Open, Classified |
EJG | None listed |
| Jun 3, 2020 | Coltene Whaledent Inc HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used t Open, Classified |
EJG | None listed |
| Jul 19, 2019 | Coltene /Whaledent AG DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-F Terminated |
EJL | None listed |
| Aug 21, 2018 | Coltene Whaledent Inc ParaPost Plus 25 Titanium Alloy Spiral Vented and
Serrated Posts
Catalog Number: P2845B
Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hol Terminated |
ELR | None listed |
| May 14, 2018 | Coltene Whaledent Inc Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, su Terminated |
EJL | None listed |
| Aug 6, 2014 | Coltene Whaledent Inc Latex Dental Dams labeled as Non-Latex Dental Dams Terminated |
EIE | None listed |