Manufacturer registered with FDA
Basic Dental Implant Systems, Inc.
Rio Rancho, NM, United States. Lists 7 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 21
- 510(k) clearances
- 62001–2008
- Markets registered in
- 512 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Basic Dental Implant Systems, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Basic Dental Implant Systems, Inc. | 6 clearances | 2001–2008 | Below |
| Canada | Health Canada | Registration holder | BASIC DENTAL IMPLANT SYSTEMS INC. | 7 | 2000–2011 | Pure Global AI |
| China | NMPA | Registration holder | 基础牙科种植体系统有限公司Basic Dental Implant Systems, Inc.基础牙科种植体系统有限公司Basic Dental Implant Systems，Inc. | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BASIC DENTAL IMPLANT SYSTEMS, INC | 2 | 2006–2006 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Basic Dental Implant Systems, Inc. | 1 | 2004–2004 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Basic Dental Implant Systems, Inc. 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 | Basic Dental Implant System | 2007 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Depth Gauge-Short&Long | 2001 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | Double End Implant Driver | 2001 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | HAND BONE DRILL | 2003 |
| Preformed CrownELZ · Class 1 | — | Maker | EMERGENCE PROFILER | 2001 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Lister | TISSUE PUNCH | 1998 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Abutment DriverAbutment Driver Multi-unitDRILL EXTENDERHand Implant DriverImplant AnalogMoter Implant Driver NP&RPMotor Abutment DriverMotor Abutment Driver Multi-unitParallel Pin short&longPath Pin RP&NP 5 morePick up Impression Coping RP&NP Short&LongPick-up Impression Coping Multi-unitScanbody NP&RPTorque WrenchTransfer Impression Coping RP&NP Short&Long | 2001 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Basic Dental Implant Systems, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Dec 2008 | K082749 | OMNI-TIGHT | DZE Root-Form Endosseous Implant |
| 9 May 2008 | K072595 | OMNI-TIGHT | DZE Root-Form Endosseous Implant |
| 20 Sep 2002 | K022912 | POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 28 Nov 2001 | K013682 | MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 1 Aug 2001 | K012299 | MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 12 Jan 2001 | K001259 | 2-PIECE POST AND CORE FOR THE B.A.S.I.C. DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Basic Dental Implant Systems, Inc.FDA reg. 1723412 | Rio Rancho, NM, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9021906). 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.