FDA Device Registration & Listing · Irvine, CA, US · Registration 3032163716
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-01-04 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2010-05-14 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2007-11-28 |
| EJQ | Wheel, Polishing Agent | Dental | Class 1 | 872.6010 | 1992-06-29 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2014-05-13 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2009-05-11 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2007-12-05 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2007-12-05 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2011-02-17 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2011-02-17 |
| EJF | Bracket, Metal, Orthodontic | Dental | Class 1 | 872.5410 | 2007-11-27 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2007-11-27 |
| DYW | Bracket, Plastic, Orthodontic | Dental | Class 2 | 872.5470 | 2007-11-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2007-12-06 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-12-13 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2007-12-06 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2011-05-26 |
| EJF | Bracket, Metal, Orthodontic | Dental | Class 1 | 872.5410 | 2012-02-07 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2012-02-07 |
| NJM | Bracket, Ceramic, Orthodontic | Dental | Class 2 | 872.5470 | 2012-02-07 |
| EIF | Accessories, Retractor, Dental | Dental | Class 1 | 872.4565 | 1978-08-31 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2007-12-05 |
| KXR | Applicator, Resin | Dental | Class 1 | 872.3140 | 2001-02-26 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2011-05-25 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2023-05-15 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2007-12-05 |
| ECO | Spring, Orthodontic | Dental | Class 1 | 872.5410 | 2024-09-19 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2008-02-25 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2007-12-05 |
| EIH | Powder, Porcelain | Dental | Class 2 | 872.6660 | 2011-03-16 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2007-12-06 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2007-12-06 |
| KCQ | Tube Impression And Matrix | Dental | Class 1 | 872.6570 | 2025-06-26 |
| ELZ | Crown, Preformed | Dental | Class 1 | 872.3330 | 2001-08-06 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2007-12-06 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2011-05-18 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2012-03-29 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2003-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2007-12-06 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2001-08-06 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2008-04-21 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2007-12-06 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2007-11-27 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2010-04-16 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2007-11-28 |
| EHJ | Disk, Abrasive | Dental | Class 1 | 872.6010 | 2001-06-12 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2010-07-15 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2007-12-06 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2007-12-05 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2008-02-14 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2008-02-14 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2008-02-14 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2008-02-14 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004943440 | 3M Purification, S. de R.L. de C. V. | San Luis Potosi Mexico, MX |
| 3003775292 | KCI POLYMEDICS BV | PEER Limburg, BE |
| 3036108847 | Solventum US LLC | Eden Prairie, MN, US |
| 3038988287 | Solventum Canada Limited | Morden Manitoba, CA |
| 3032763783 | Solventum Poland Manufacturing SP. ZO.O | Wroclaw Dolnoslaskie, PL |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K952662 | Jeneric/Pentron, Inc. | COMP=FLOW | 1995-08-28 |
| K171147 | Bisco, Inc. | REVEAL Bulk | 2017-08-04 |
| K770922 | Espe GmbH (Us) | DENTAL RESTORATIVE IN CAPSULES | 1977-06-01 |
| K153476 | Kuraray Noritake Dental, Inc. | KATANA AVENCIA Block | 2016-08-23 |
| K020499 | Jeneric/Pentron, Inc. | BOND-3 ADHESIVE | 2002-04-22 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0028-2020 | Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany | 2 | Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.). |
| Z-0035-2008 | Heraeus Kulzer Inc., Dental Products Division | 2 | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710. |
| Z-0036-2008 | Heraeus Kulzer Inc., Dental Products Division | 2 | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222. |
| Z-0013-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Z-0014-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3017374693 | STRATASYS LTD - Headquarter | Rehovot Central, IL |
| 3006694515 | indigodental GmbH | Pinneberg Schleswig-Holstein, DE |
| 3012421607 | MAINLINE MEDICAL DENTAL SUPPLY | North York Ontario, CA |
| 3043226252 | ZAPALIGN LLC | Fort Lauderdale, FL, US |
| 9612352 | IVOCLAR VIVADENT AG | SCHAAN, LI |
3032163716 when referencing this establishment in official correspondence.