Data / Medical devices / United States / Biotech Dental
Biotech Dental: FDA-registered device maker in Englewood, NJ, United States, 4 510(k) clearances
Biotech Dental is registered with the FDA (registration 3010730876) in Englewood, NJ, United States. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 15, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010730876
- Address
- 145 Cedar Lane Suite 205, Englewood, NJ, United States, 07631
- Owner or operator
- Biotech Dental (10083785)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 19, 2021
- Registered through
- 2027
- Brand names listed
- ATP38, Implant Prosthetic Kit, Implant Surgical Kit, Kontact, PRF System, Reflect, Smilers, Y-Brush
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment | accessdata.fda.gov |
| Aligner, Sequential | NXC | 2 | Complaint file establishment | accessdata.fda.gov |
| Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | QBV | 1 | Complaint file establishment | accessdata.fda.gov |
| Dental Implant Surgical Tray | OFY | 1 | Complaint file establishment | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 15, 2022 | K213997 | Kontact Dental Implant System | DZE | Substantially Equivalent | Biotech Dental, Sas | accessdata.fda.gov |
| September 20, 2021 | K212961 | SMILERS | NXC | Substantially Equivalent | Biotech Dental Smilers, Sas | accessdata.fda.gov |
| June 18, 2021 | K210220 | Kontact Dental Implant System | DZE | Substantially Equivalent | Biotech Dental, Sas | accessdata.fda.gov |
| March 29, 2019 | K180924 | Reflect Implant System | DZE | Substantially Equivalent | Ids - Integrated Dental Systems | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
- All makers of Aligner, Sequential
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Toothbrush, Powered
Updated July 15, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.