Zimmer Dental, Inc.: FDA clearances and approvals
Zimmer Dental, Inc. has 40 FDA 510(k) clearances (first 2005, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time: 98 days. openFDA lists 40 product recalls by a recalling firm named Zimmer Dental, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 180 |
| 2013 | 1 | 123 |
| 2014 | 6 | 120 |
| 2015 | 3 | 140 |
| 2016 | 0 | — |
| 2017 | 1 | 460 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Zimmer Dental, Inc.'s cleared 510(k)s took a median 460 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 21 | 21 |
| DZE | Implant, Endosseous, Root-Form | 19 | 19 |
Review panels
- Dental (40)
Most recent Zimmer Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160398 | MRI Compatibility for Existing Zimmer Dental Implant Systems | DZE | 2017-05-17 | 460 |
| K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | NHA | 2015-06-25 | 197 |
| K143528 | Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System | NHA | 2015-05-01 | 140 |
| K142572 | Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System | NHA | 2015-01-21 | 131 |
| K142082 | ZIMMER 3.1MM DENTAL IMPLANT;2.9MM ANGLED ABUTMENT;STRAIGHT HEX, 2.9MM CONTOUR ABUTEMENT | DZE | 2014-10-28 | 89 |
| K141544 | ZIMMER ZFX TITANIUM ABUTMENT FOR BIOMET 3I CERTAIN IMPLANT SYSTEM | NHA | 2014-10-22 | 134 |
| K141120 | ZIMMER ZFX TITANIUM ABUTMENT FOR STRAUMANN BONE LEVEL IMPLANT SYSTEM | NHA | 2014-07-29 | 90 |
| K133551 | ZIMMER ZFX TITANIUM BASE ABUTMENT FOR TAPERED SCREWVENT IMPLANT SYSTEM | NHA | 2014-07-18 | 241 |
| K134045 | ZIMMER ZFX TITANIUM ABUTMENT, BASE ABUTMENT AND ABUTMENT BLANK FOR NOBELACTIVE IMPLANT SYSTEM | NHA | 2014-04-25 | 115 |
| K133339 | ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED | DZE | 2014-03-04 | 125 |
30 earlier clearances. See the full list in Caduvo.
Recalls
40 product recalls in 11 recall events; 0 initiated in the last five years. Most recent: 2018-05-10.
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 Zimmer Dental, Inc. have?
Zimmer Dental, Inc. has 40 FDA 510(k) clearances (first 2005, latest 2017), across 2 product codes in 1 review panel.
How long does FDA take to clear Zimmer Dental, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Zimmer Dental, Inc.'s cleared 510(k)s is 98 days.
What devices does Zimmer Dental, Inc. make?
Its most frequent FDA product codes are NHA (Abutment, Implant, Dental, Endosseous, 21); DZE (Implant, Endosseous, Root-Form, 19).
Has Zimmer Dental, Inc. had device recalls?
openFDA lists 40 product recalls in 11 recall events by a recalling firm whose name matches Zimmer Dental, Inc; the most recent began 2018-05-10. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 40 Zimmer Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NHA, Zimmer Dental, 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.