FDA Device Registration & Listing · TORONTO Ontario, CA · Registration 3008912871
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| EAT | Tester, Pulp | Dental | Class 2 | 872.1720 | 2020-02-09 |
| EIE | Dam, Rubber | Dental | Class 1 | 872.6300 | 2020-08-19 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | Class 1 | 872.6030 | 2022-12-31 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2023-01-01 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-11-26 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-05-12 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-12-20 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2023-06-14 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-12-20 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2023-12-21 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-05-12 |
| GAL | Suture, Absorbable, Natural | General, Plastic Surgery | Class 2 | 878.4830 | 2020-02-10 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2022-05-12 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2020-08-19 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2020-08-19 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2020-08-19 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2023-01-01 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2022-05-12 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2024-10-06 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-12-24 |
| EJJ | Alloy, Amalgam | Dental | Class 2 | 872.3070 | 2018-03-07 |
| DZS | Capsule, Dental, Amalgam | Dental | Class 1 | 872.3110 | 2018-03-07 |
| ELY | Mercury | Dental | Class 2 | 872.3070 | 2018-03-07 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2018-05-02 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-12-20 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2022-05-12 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2023-01-01 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-11-26 |
| IWZ | Film, Radiographic | Radiology | Class 1 | 892.1840 | 2017-12-25 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-03-13 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-11-26 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2017-11-26 |
| KIF | Resin, Root Canal Filling | Dental | Class 2 | 872.3820 | 2020-02-09 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-11-26 |
| MZW | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | Dental | Class 2 | 872.3275 | 2017-11-26 |
| EMB | Zinc Oxide Eugenol | Dental | Class 1 | 872.3275 | 2017-12-25 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2022-12-31 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2018-12-30 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2023-12-21 |
| EFB | Handpiece, Air-Powered, Dental | Dental | Class 1 | 872.4200 | 2019-03-12 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-11-26 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-11-26 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2017-11-26 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2017-12-20 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2018-03-07 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2020-08-19 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2020-08-19 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2017-11-26 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2020-02-10 |
| ELC | Scaler, Ultrasonic | Dental | Class 2 | 872.4850 | 2024-10-06 |
| ELW | Material, Impression | Dental | Class 2 | 872.3660 | 2019-03-13 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2019-09-19 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2019-09-19 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | Class 2 | 872.3765 | 2020-12-03 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2020-12-03 |
| EBD | Coating, Filling Material, Resin | Dental | Class 2 | 872.3310 | 2020-08-19 |
| EIH | Powder, Porcelain | Dental | Class 2 | 872.6660 | 2017-12-20 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2020-08-19 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | Class 2 | 872.3760 | 2017-12-20 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-12-25 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-11-08 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | Dental | Class 1 | 872.3740 | 2024-12-05 |
| EHJ | Disk, Abrasive | Dental | Class 1 | 872.6010 | 2017-12-25 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2020-08-19 |
| EBG | Crown And Bridge, Temporary, Resin | Dental | Class 2 | 872.3770 | 2024-10-06 |
| POW | Crown And Bridge, Long-Term Temporary, Resin | Dental | Class 2 | 872.3770 | 2024-10-06 |
| KLE | Agent, Tooth Bonding, Resin | Dental | Class 2 | 872.3200 | 2019-09-19 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2017-11-08 |
| EMA | Cement, Dental | Dental | Class 2 | 872.3275 | 2017-11-26 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2020-08-19 |
| EBF | Material, Tooth Shade, Resin | Dental | Class 2 | 872.3690 | 2020-08-19 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Dental | Class 2 | 872.3750 | 2020-02-09 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K040797 | Britesmile, Inc. | BRITESMILE MASKING CREAM | 2004-04-02 |
| K121698 | Dentsply International, Inc. | NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN | 2012-08-06 |
| K952614 | Dentsply Intl. | JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL | 1996-08-13 |
| K020499 | Jeneric/Pentron, Inc. | BOND-3 ADHESIVE | 2002-04-22 |
| K801093 | Dentsply Intl. | PRISMA-BOND | 1980-05-20 |
| 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 |
|---|---|---|
| 9680845 | SDS de Mexico S. de R.L. de C.V. | MEXICALI, B.C. C.P. Baja California, MX |
| 3004425647 | PREMIUM PLUS DENTAL SUPPLIES INC | BROOKLYN, NY, US |
| 2024312 | Kerr Corporation | ORANGE, CA, US |
| 3038718579 | OKETZ LOGISTICS LLC | Coral Gables, FL, US |
| 1937100 | Ortho Solutions LC | Lake Saint Louis, MO, US |
3008912871 when referencing this establishment in official correspondence.