Registered with FDA
Dentaline LLC
Brooklyn, NY, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Dentaline LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Lister | Biodentadentaswiss | 2019 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Lister | Biodentadentaswiss | 2019 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | Biodentadentaswiss | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Dentaline LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Biodenta Swiss AG (9).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Dec 2015 | K151295 | Biodenta Customized Abutment - Titanium | Biodenta Swiss AG | NHA Endosseous Dental Implant Abutment |
| 2 Jul 2015 | K150296 | Biodenta Customized Abutment-Hybrid | Biodenta Swiss AG | NHA Endosseous Dental Implant Abutment |
| 13 Jun 2014 | K133884 | BIODENTA DENTAL IMPLANT SYSTEM-BONE LEVEL TAPERED D3.0 AND L6.5MM | Biodenta Swiss AG | DZE Root-Form Endosseous Implant |
| 30 May 2013 | K123491 | BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENT | Biodenta Swiss AG | NHA Endosseous Dental Implant Abutment |
| 3 May 2013 | K122559 | BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS | Biodenta Swiss AG | NHA Endosseous Dental Implant Abutment |
| 28 Mar 2013 | K123512 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MM | Biodenta Swiss AG | DZE Root-Form Endosseous Implant |
| 19 Mar 2013 | K123415 | BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED | Biodenta Swiss AG | DZE Root-Form Endosseous Implant |
| 15 Sep 2011 | K111003 | BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL | Biodenta Swiss AG | DZE Root-Form Endosseous Implant |
| 3 Jun 2010 | K093630 | BIODENTA DENTAL IMPLANT SYSTEM | Biodenta Swiss AG | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTALINE LLCFDA reg. 3016172557 | Brooklyn, NY, United States | Complaint file establishment |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062105). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.