Calcitek, Inc.
United StatesFDA applicant, unverified
- Devices
- 21
What Calcitek, Inc. makes
Calcitek, Inc. manufactures dental implant systems, including the INTEGRAL III, INTEGRAL PLUS, INTEGRAL V, and INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEMS, as well as SPLINE DENTAL IMPLANT SYSTEMS and CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS. The company also produces dental accessories such as the O-RING PROSTHETIC ATTACHMENT DEVICE, CALCITEK TORQUE WRENCH SYSTEM, BUR, DENTAL (76EJL), CASTABLE ABUTMENTS, and CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG.
Calcitek, Inc. is based in the US and its devices are listed in the FDA 510(k) registry. All of their products are classified as Class II medical devices, which are subject to specific regulatory controls but generally require less stringent premarket notification than Class III devices.
Catalogue
Search and filter all 21 devicesFrequently asked questions
How many devices does Calcitek, Inc. have in the registry?
The registry currently lists 21 devices for Calcitek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Calcitek, Inc.'s devices?
Among its 21 most recently registered devices, Calcitek, Inc. has devices listed in FDA 510(k) (21 devices).
What risk classes do Calcitek, Inc.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Calcitek, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Calcitek, Inc. in the registry?
The most recently registered devices listed for Calcitek, Inc. include O-RING PROSTHETIC ATTACHMENT DEVICE, CALCITEK TORQUE WRENCH SYSTEM, INTEGRAL III BIOINTEGRATED DENTAL IMPLANT SYSTEM and INTEGRAL PLUS BIOINTEGRATED DENTAL IMPLANT SYSTEM.