# Calcitek, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 21 (1984–1997): 21 510(k) clearances
- Product codes: DZE (20), LYC (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 9 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Sulzer Dental, Inc.: 4 (https://510kreport.com/company/sulzer-dental)
- Zimmer Dental, Inc.: 2 (https://510kreport.com/company/zimmer-dental)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)
- Usbiomaterials Corp.: 1 (https://510kreport.com/company/usbiomaterials)
- Bioform, Inc.: 1 (https://510kreport.com/company/bioform)

## Its most-cited devices
- K944327: Integral VI Biointegrated Dental Implant System (1995), cited by 2
- K852682: Calcitite Bone Graft Mat/Oral & Maxillofacial Surg (1985), cited by 2
- K946311: Integral Vii 3.25MM Biointegrated Dental Implant System (1995), cited by 1
- K962576: Spline X Endosseous Dental Implant System (1997), cited by 1
- K931440: Calcitek Torque Wrench System (1994), cited by 1
- K943180: Integral IV Biointegrated Dental Implant System (1995), cited by 1

## Recent decisions
- K962576: Spline X Endosseous Dental Implant System (Feb 10, 1997)
- K962106: Spline Dental Implant Systems (Aug 29, 1996)
- K955619: 5.0MM Spline Endosseous Dental Implant Systems (Mar 8, 1996)
- K943604: Integral V Biointegrated Dental Implant System (Feb 8, 1996)
- K960021: Calcitek HA-Coated Endosseous Dental Implant Systems (Feb 8, 1996)
- K946345: Integral Viii Biointegrated Dental Implant System (Nov 15, 1995)
- K946319: Integral Vii 4.9MM Biointegrated Dental Implant System (Nov 15, 1995)
- K946311: Integral Vii 3.25MM Biointegrated Dental Implant System (Oct 4, 1995)

Source page: https://510kreport.com/company/calcitek