Data / Medical devices / United States / Dentaline LLC
Dentaline LLC: FDA-registered device maker in Brooklyn, NY, United States, 9 510(k) clearances
Dentaline LLC is registered with the FDA (registration 3016172557) in Brooklyn, NY, United States. It lists 3 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 1, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016172557
- Address
- 500 4th Ave Apt 2C, Brooklyn, NY, United States, 11215
- Owner or operator
- Dentaline LLC (10062105)
- Roles
- Complaint file establishment
- First device listed
- December 24, 2019
- Registered through
- 2026
- Brand names listed
- Biodenta, dentaswiss
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Complaint file establishment | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | 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 |
|---|---|---|---|---|---|---|
| December 1, 2015 | K151295 | Biodenta Customized Abutment - Titanium | NHA | Substantially Equivalent | Biodenta Swiss AG | accessdata.fda.gov |
| July 2, 2015 | K150296 | Biodenta Customized Abutment-Hybrid | NHA | Substantially Equivalent | Biodenta Swiss AG | accessdata.fda.gov |
| June 13, 2014 | K133884 | BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM | DZE | Substantially Equivalent | Biodenta Swiss AG | accessdata.fda.gov |
| May 30, 2013 | K123491 | BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT | NHA | Substantially Equivalent | Biodenta Swiss AG | accessdata.fda.gov |
| May 3, 2013 | K122559 | BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS | NHA | Substantially Equivalent | Biodenta Swiss AG | accessdata.fda.gov |
| March 28, 2013 | K123512 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM | DZE | Substantially Equivalent | Biodenta Swiss AG | accessdata.fda.gov |
| March 19, 2013 | K123415 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED | DZE | Substantially Equivalent | Biodenta Swiss AG | accessdata.fda.gov |
| September 15, 2011 | K111003 | BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL | DZE | Substantially Equivalent | Biodenta Swiss AG | accessdata.fda.gov |
| June 3, 2010 | K093630 | BIODENTA DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Biodenta Swiss AG | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
Updated December 1, 2015. 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.