FDA Device Registration & Listing · CAMARILLO, CA, US · Registration 2014676
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 |
|---|---|---|---|---|---|
| EJH | Alloy, Metal, Base | Dental | Class 2 | 872.3710 | 2019-06-26 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2020-07-31 |
| DZM | Needle, Dental | Dental | Class 1 | 872.4730 | 1992-11-30 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2022-07-21 |
| EJH | Alloy, Metal, Base | Dental | Class 2 | 872.3710 | 2019-06-26 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2022-07-21 |
| EFN | Cotton, Roll | Dental | Class 1 | 872.6050 | 1992-11-30 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2019-01-04 |
| KHE | Reagent, Occult Blood | Hematology | Class 2 | 864.6550 | 2019-08-13 |
| EEA | Plate, Base, Shellac | Dental | Class 1 | 872.6200 | 2019-05-13 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2022-07-21 |
| NDP | Accessories, Implant, Dental, Endosseous | Dental | Class 1 | 872.3980 | 2019-05-13 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-06-26 |
| EJH | Alloy, Metal, Base | Dental | Class 2 | 872.3710 | 2019-06-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-08-29 |
| JES | Floss, Dental | Dental | Class 1 | 872.6390 | 2020-09-22 |
| EBH | Material, Impression Tray, Resin | Dental | Class 1 | 872.3670 | 2019-05-13 |
| EID | Syringe, Restorative And Impression Material | Dental | Class 1 | 872.4565 | 1992-11-30 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K810521 | C.Vaupel Dental, Inc. | CO-SPAN 13.5 CASTING ALLOY | 1981-03-17 |
| K162333 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo One Step Fecal Occult Blood (FOB) Test | 2017-05-14 |
| K020499 | Jeneric/Pentron, Inc. | BOND-3 ADHESIVE | 2002-04-22 |
| K801093 | Dentsply Intl. | PRISMA-BOND | 1980-05-20 |
| K061981 | Apex Dental Materials, Inc. | SURPASS | 2006-07-31 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| 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. |
| 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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3029528165 | ACNIS TITANIUM & ALLOYS INC. | Elk Grove Village, IL, US |
| 3001157343 | RANSOM & RANDOLPH. LLC. | Maumee, OH, US |
| 3010605319 | Adentatec GmbH | Woerth am Main Bavaria, DE |
| 3039443707 | SHANGHAI FRONTIER MATERIAL TECH CO., LTD. | Shanghai, CN |
| 3013551048 | The Argen Corporation | San Diego, CA, US |
2014676 when referencing this establishment in official correspondence.