Not currently registered with FDA under this name
Calcitek, Inc.
Carlsbad, CA, United States. Named as applicant on 21 dental 510(k) clearances between 1984 and 1997. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 211984–1997
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name Calcitek, 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 | Applicant | Calcitek, Inc. | 21 clearances | 1984–1997 | Below |
| Taiwan | TFDA | Manufacturer | CALCITEK,INC. | 2 | 1985–1986 | 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
510(k) clearances
Clearances on which FDA names Calcitek, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Feb 1997 | K962576 | SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 29 Aug 1996 | K962106 | SPLINE DENTAL IMPLANT SYSTEMS | DZE Root-Form Endosseous Implant |
| 8 Mar 1996 | K955619 | 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS | DZE Root-Form Endosseous Implant |
| 8 Feb 1996 | K960021 | CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS | DZE Root-Form Endosseous Implant |
| 8 Feb 1996 | K943604 | INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 15 Nov 1995 | K946345 | INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 15 Nov 1995 | K946319 | INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 4 Oct 1995 | K946311 | INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 21 Sep 1995 | K943180 | INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 16 May 1995 | K944327 | INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 5 May 1995 | K941608 | INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING | DZE Root-Form Endosseous Implant |
| 1 Aug 1994 | K925490 | INTEGRAL III BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 26 Jan 1994 | K931440 | CALCITEK TORQUE WRENCH SYSTEM | DZE Root-Form Endosseous Implant |
| 5 Nov 1993 | K932274 | INTEGRAL III DENTAL IMPLANT ABUTMENT | DZE Root-Form Endosseous Implant |
| 5 Nov 1993 | K923562 | INTERGRAL III DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 5 Feb 1992 | K915597 | BUR,DENTAL (76EJL) | DZE Root-Form Endosseous Implant |
| 11 Feb 1991 | K900694 | CASTABLE ABUTMENTS | DZE Root-Form Endosseous Implant |
| 28 Jun 1990 | K900549 | INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 22 Jun 1990 | K900545 | O-RING PROSTHETIC ATTACHMENT DEVICE | DZE Root-Form Endosseous Implant |
| 23 Sep 1985 | K852682 | CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG | LYC Synthetic Bone Grafting Material |
| 13 Apr 1984 | K840750 | HYDROXYLAPATITE COATED ENDOSSEOUS DENT | DZE Root-Form Endosseous Implant |
Some of these clearances are listed with FDA today by another company: ZimVie US Corp LLC (10).
Sources
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 of the most recent filing, which can be a US agent.