FDA Device Registration & Listing · Anaheim, CA, US · Registration 3010664129
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 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-11-14 |
| KOJ | Airbrush | Dental | Class 2 | 872.6080 | 2016-11-14 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-11-14 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-11-14 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2019-01-09 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-11-14 |
| 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 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-11-14 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-01-08 |
| EFX | Protector, Silicate | Dental | Class 1 | 872.6670 | 2017-08-02 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-11-14 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-12-19 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-11-14 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-01-08 |
| EIE | Dam, Rubber | Dental | Class 1 | 872.6300 | 2019-01-09 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-11-14 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2014-10-13 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-11-14 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-11-14 |
| 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 |
| 2023950 | ZEST ANCHORS, LLC | Carlsbad, 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-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. |
| 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 |
3010664129 when referencing this establishment in official correspondence.