Calcitek, Inc.: FDA clearances and approvals
Calcitek, Inc. has 21 FDA 510(k) clearances (first 1984, latest 1997), across 2 product codes in 1 review panel. Median 510(k) review time: 256 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 20 | 20 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
Review panels
- Dental (21)
Most recent Calcitek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K962576 | SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | 1997-02-10 | 224 |
| K962106 | SPLINE DENTAL IMPLANT SYSTEMS | DZE | 1996-08-29 | 90 |
| K955619 | 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMS | DZE | 1996-03-08 | 88 |
| K960021 | CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMS | DZE | 1996-02-08 | 37 |
| K943604 | INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | 1996-02-08 | 563 |
| K946345 | INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | 1995-11-15 | 320 |
| K946319 | INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | 1995-11-15 | 322 |
| K946311 | INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | 1995-10-04 | 280 |
| K943180 | INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | 1995-09-21 | 447 |
| K944327 | INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM | DZE | 1995-05-16 | 256 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Calcitek, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Calcitek, Inc. have?
Calcitek, Inc. has 21 FDA 510(k) clearances (first 1984, latest 1997), across 2 product codes in 1 review panel.
How long does FDA take to clear Calcitek, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Calcitek, Inc.'s cleared 510(k)s is 256 days.
What devices does Calcitek, Inc. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 20); LYC (Bone Grafting Material, Synthetic, 1).
Has Calcitek, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Calcitek, Inc. Related entities may recall under other names.
Next steps
- See all 21 Calcitek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Calcitek, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.