Manufacturer registered with FDA
ARCH Medical Solutions - Escondido LLC
Escondido, CA, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What ARCH Medical Solutions - Escondido 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 | Maker | Abutment, implant, dental, endosseousIMPLANT, ENDOSSEOUS, ROOT-FORM | 2013 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Abutment, implant, dental, endosseous | 2013 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | PLATE, BONE | 2012 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Accessories, implant, dental, endosseous | 2013 |
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
ARCH Medical Solutions - Escondido 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: Aidi Biomedical, LLC (2), Zimmer Dental, Inc. (2), Biomet 3i, LLC (2), Sulzer Dental, Inc. (2), Sulzer Calcitek, Inc. (2), B&W Srl (1), Idi Biomedical, LLC (1), Macropore Biosurgery, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 12 Dec 2013 | K123861 | AIDI DENTAL IMPLANT SYSTEM | Aidi Biomedical, LLC | DZE Root-Form Endosseous Implant |
| 8 Nov 2012 | K120873 | ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM | Zimmer Dental, Inc. | NHA Endosseous Dental Implant Abutment |
| 7 Sep 2012 | K120875 | B&W DENTAL IMPLANT SYSTEM | B&W Srl | DZE Root-Form Endosseous Implant |
| 22 Nov 2010 | K101755 | AIDI DENTAL IMPLANT SYSTEM | Aidi Biomedical, LLC | DZE Root-Form Endosseous Implant |
| 30 Nov 2009 | K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION | Biomet 3i, LLC | NHA Endosseous Dental Implant Abutment |
| 7 Nov 2008 | K081806 | IDI IMPLANT SYSTEM | Idi Biomedical, LLC | DZE Root-Form Endosseous Implant |
| 20 Dec 2007 | K072642 | BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS | Biomet 3i, LLC | NHA Endosseous Dental Implant Abutment |
| 13 Oct 2005 | K052600 | ZIMMER DENTAL HEX-LOCK PREPARED ABUTMENT (STRAIGHT & ANGLED) | Zimmer Dental, Inc. | NHA Endosseous Dental Implant Abutment |
| 20 Mar 2002 | K014175 | SULZER DENTAL CERAMIC SYSTEM-HEXLOCK | Sulzer Dental, Inc. | NHA Endosseous Dental Implant Abutment |
| 18 Sep 2001 | K012413 | MACROPORE FX, PS, NS, LP | Macropore Biosurgery, Inc. | JEY Bone Plate |
| 21 May 2001 | K011028 | SCREW-VENT DENTAL IMPLANT SYSTEM | Sulzer Dental, Inc. | DZE Root-Form Endosseous Implant |
| 19 Jan 2001 | K010073 | SPLINE DENTAL IMPLANT SYSTEM | Sulzer Calcitek, Inc. | DZE Root-Form Endosseous Implant |
| 8 Dec 2000 | K002614 | ADVENT IMPLANT SYSTEM | Core-Vent Corp. | DZE Root-Form Endosseous Implant |
| 22 Sep 1998 | K982305 | SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT | Sulzer Calcitek, Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ARCH Medical Solutions - Escondido LLCFDA reg. 2029005 | ESCONDIDO, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9098779). 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.