FDA Device Registration & Listing · Carlsbad, CA, US · Registration 2023950
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-11-14 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2011-03-29 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2019-10-23 |
| POW | Crown And Bridge, Long-Term Temporary, Resin | Dental | Class 2 | 872.3770 | 2019-10-23 |
| KOJ | Airbrush | Dental | Class 2 | 872.6080 | 2016-12-19 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2019-01-09 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2016-12-19 |
| EGG | Attachment, Precision, All | Dental | Class 1 | 872.3165 | 2011-03-29 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2024-06-18 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2016-12-19 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-12-19 |
| EIA | Unit, Operative Dental | Dental | Class 1 | 872.6640 | 2016-12-19 |
| EJL | Bur, Dental | Dental | Class 1 | 872.3240 | 2017-08-24 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-01-08 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-11-14 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-11-14 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2014-10-13 |
| EJQ | Wheel, Polishing Agent | Dental | Class 1 | 872.6010 | 2019-01-09 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2009-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-11-14 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-11-14 |
| ELR | Post, Root Canal | Dental | Class 1 | 872.3810 | 2016-12-19 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-11-14 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2016-03-10 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2023-06-08 |
| EIA | Unit, Operative Dental | Dental | Class 1 | 872.6640 | 2016-12-19 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-01-08 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-02-14 |
| EID | Syringe, Restorative And Impression Material | Dental | Class 1 | 872.4565 | 2016-12-19 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-11-20 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-09-18 |
| KXR | Applicator, Resin | Dental | Class 1 | 872.3140 | 2016-12-19 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2016-12-19 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2026-04-23 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2016-12-19 |
| EIE | Dam, Rubber | Dental | Class 1 | 872.6300 | 2019-01-09 |
| EFL | Forceps, Dressing, Dental | Dental | Class 1 | 872.4565 | 2019-01-09 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2013-03-04 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2017-08-24 |
| ELR | Post, Root Canal | Dental | Class 1 | 872.3810 | 2011-03-29 |
| KOJ | Airbrush | Dental | Class 2 | 872.6080 | 2016-12-08 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-11-14 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-11-14 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 1992-12-02 |
| EHL | Point, Abrasive | Dental | Class 1 | 872.6010 | 2017-06-13 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2015-10-23 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2016-12-19 |
| LFC | Device, Caries Detection | Dental | Class 2 | 872.1740 | 2016-12-19 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-12-19 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2007-12-05 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 1992-12-02 |
| EKB | Explorer, Operative | Dental | Class 1 | 872.4565 | 2017-07-11 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2016-11-14 |
No US Agent registered (Local establishment).
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3006796211 | ZEST ANCHORS, LLC | Escondido, CA, US |
| 3010664129 | Danville Materials Research Center | Anaheim, CA, US |
| 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 |
| K940776 | Kreativ, Inc. | KREATIV MODEL KV-1 | 1994-12-21 |
| 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-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. |
| Z-0015-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment MU, Cat. No. 30-70103 - 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-0016-2022 | Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel | 1 | Scan Abutment SU, Cat. No. 30-70104 - 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 |
2023950 when referencing this establishment in official correspondence.