FDA Device Registration & Listing · Lakewood, NJ, US · Registration 3012187973
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2019-11-21 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-01-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-11-21 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-06-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-01-24 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-03-17 |
| EHJ | Disk, Abrasive | Dental | Class 1 | 872.6010 | 2016-08-23 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-11-17 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2019-05-23 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-10-27 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-08-22 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2022-04-08 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-11-13 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-09-15 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2019-10-13 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2019-08-29 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2019-05-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-12-28 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2016-12-28 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2021-08-05 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2019-06-27 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2019-06-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-06-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-08-22 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-07-22 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2017-01-24 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2025-09-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2025-09-26 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2025-09-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-08-22 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-08-22 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2018-12-12 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-08-22 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-05-27 |
| EKQ | Preparer, Root Canal Endodontic | Dental | Class 1 | 872.4565 | 2021-08-05 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-10-13 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-09-14 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2017-10-25 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-10-25 |
| LMF | Agent, Absorbable Hemostatic, Collagen Based | General, Plastic Surgery | Class 3 | 878.4490 | 2025-09-29 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2020-02-17 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-10-13 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-09-14 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2016-09-14 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-09-14 |
| KXR | Applicator, Resin | Dental | Class 1 | 872.3140 | 2022-06-20 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2016-08-17 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-09-14 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2017-03-24 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-12-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-11-28 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2022-11-02 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-09-14 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-08-09 |
| IWZ | Film, Radiographic | Radiology | Class 1 | 892.1840 | 2019-10-13 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-11-28 |
| KOQ | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) | Dental | Class 1 | 872.3410 | 2026-02-18 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-08-28 |
| DZN | Instruments, Dental Hand | Dental | Class 1 | 872.4565 | 2019-07-05 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-09-15 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-07-22 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2019-08-19 |
| MVL | Cord, Retraction | Unknown | Class U | N/A | 2023-03-16 |
| EIH | Powder, Porcelain | Dental | Class 2 | 872.6660 | 2022-05-16 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2022-05-16 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-10-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-07-11 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-10-27 |
| EBH | Material, Impression Tray, Resin | Dental | Class 1 | 872.3670 | 2022-06-20 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2022-11-02 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-11-21 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2018-10-29 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-01-24 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-05-23 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-11-28 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2017-02-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-10-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2018-02-19 |
| EBH | Material, Impression Tray, Resin | Dental | Class 1 | 872.3670 | 2017-01-24 |
| EIH | Powder, Porcelain | Dental | Class 2 | 872.6660 | 2016-10-27 |
| JEP | Retainer, Matrix | Dental | Class 1 | 872.4565 | 2018-10-29 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2020-03-31 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-11-28 |
| EHD | Unit, X-Ray, Extraoral With Timer | Dental | Class 2 | 872.1800 | 2019-07-05 |
| LRJ | Disinfectant, Medical Devices | General Hospital | Class 1 | 880.6890 | 2026-02-18 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2018-02-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-04-09 |
| NHA | Abutment, Implant, Dental, Endosseous | Dental | Class 2 | 872.3630 | 2025-05-08 |
| DZE | Implant, Endosseous, Root-Form | Dental | Class 2 | 872.3640 | 2025-05-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-10-13 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-11-28 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2020-02-25 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-11-13 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-05-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2018-02-27 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-02-13 |
| BYG | Mask, Oxygen | Anesthesiology | Class 1 | 868.5580 | 2026-03-05 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-11-17 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2019-05-23 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-09-14 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2019-08-16 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2020-02-17 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2018-02-27 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-12-08 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2018-11-30 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2016-10-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-01-24 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2018-09-12 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-12-28 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-07-22 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-07-22 |
| MZW | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | Dental | Class 2 | 872.3275 | 2016-07-22 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-11-28 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2016-12-28 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-07-22 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-12-28 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2022-04-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-02-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2020-02-25 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2017-11-06 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2017-01-30 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2019-11-21 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2021-08-25 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-12-04 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-11-21 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2020-01-28 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-11-13 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | Class 2 | 872.6070 | 2022-06-20 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2022-11-02 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-11-28 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2019-08-19 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2016-10-27 |
| EBD | Coating, Filling Material, Resin | Dental | Class 2 | 872.3310 | 2018-10-29 |
| FXX | Mask, Surgical | General, Plastic Surgery | Class 2 | 878.4040 | 2020-07-20 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2022-06-20 |
| EIG | Retractor, All Types | Dental | Class 1 | 872.4565 | 2018-09-06 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2017-01-30 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2016-09-14 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2018-10-29 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-11-01 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-07-22 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2018-12-12 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2019-07-11 |
| EJK | Liner, Cavity, Calcium Hydroxide | Dental | Class 2 | 872.3250 | 2022-12-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2019-02-13 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-08-22 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-12-08 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-03-06 |
| EID | Syringe, Restorative And Impression Material | Dental | Class 1 | 872.4565 | 2019-06-27 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-07-22 |
| ELY | Mercury | Dental | Class 2 | 872.3070 | 2017-01-26 |
| EJJ | Alloy, Amalgam | Dental | Class 2 | 872.3070 | 2017-01-26 |
| DZS | Capsule, Dental, Amalgam | Dental | Class 1 | 872.3110 | 2017-01-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2018-09-06 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2016-11-28 |
| EIH | Powder, Porcelain | Dental | Class 2 | 872.6660 | 2016-10-27 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-07-21 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2019-08-08 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2016-11-28 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2016-12-08 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-10-13 |
| EMB | Zinc Oxide Eugenol | Dental | Class 1 | 872.3275 | 2017-03-03 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-07-21 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2019-10-13 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-01-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2020-03-09 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2021-08-05 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-05-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2023-08-07 |
| LBH | Varnish, Cavity | Dental | Class 2 | 872.3260 | 2019-10-13 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-05-27 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2017-02-27 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2018-12-10 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2020-08-26 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K972485 | Arent, Fox, Kintner, Plotkin & Kahn | CIMPAT N | 1997-09-08 |
| K982895 | Sterngold/Implamed | STERNOMEGA COMPOMER CEMENT | 1998-10-09 |
| K033068 | Voco GmbH | IONOFIL COLOR AC | 2003-10-31 |
| K062064 | Southern Dental Industries, Inc. | RIVA BOND LC | 2006-11-09 |
| K940030 | Bisco, Inc. | BISCO COMPOSITE | 1994-02-04 |
| 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-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-0017-2017 | Ivoclar Vivadent, Inc. | 2 | Zenostar MT Color Impulse blue, Art. no. 681165
Product Usage:
For coloring dental porcelain |
| Z-0018-2017 | Ivoclar Vivadent, Inc. | 2 | Zenostar MT Color Impulse brown, art. no. 681169
Product Usage:
For coloring dental porcelain |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 2022039 | SCIENTIFIC PHARMACEUTICALS, INC. | POMONA, CA, US |
| 3038718579 | OKETZ LOGISTICS LLC | Coral Gables, FL, US |
| 2515379 | DENTSPLY LLC | MILFORD, DE, US |
| 9680845 | SDS de Mexico S. de R.L. de C.V. | MEXICALI, B.C. C.P. Baja California, MX |
| 8044164 | DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH | HAMBURG, DE |
3012187973 when referencing this establishment in official correspondence.