Implant Direct Sybron Manufacturing, LLC: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Implant Direct Sybron Manufacturing, LLC” (first 2013, latest 2023), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 209 days. Since 2017 the median was 170 days, against 189 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Envista (Nobel Biocare, Ormco, Kerr), based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 2 | 210 |
| 2014 | 0 | — |
| 2015 | 2 | 244 |
| 2016 | 1 | 263 |
| 2017 | 1 | 306 |
| 2018 | 1 | 85 |
| 2019 | 1 | 132 |
| 2020 | 4 | 208 |
| 2021 | 2 | 188 |
| 2022 | 0 | — |
| 2023 | 3 | 192 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Implant Direct Sybron Manufacturing, LLC took a median 170 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 189 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 6 | 6 |
| NHA | Abutment, Implant, Dental, Endosseous | 6 | 6 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 3 | 3 |
| DZI | Drill, Bone, Powered | 2 | 2 |
Review panels
- Dental (14)
- General Hospital (3)
Most recent Implant Direct Sybron Manufacturing, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231087 | Guided Surgery Kit | DZI | 2023-08-16 | 121 |
| K223535 | SMARTbase Abutment System | NHA | 2023-06-20 | 209 |
| K222211 | Implant Direct Dental Implant Systems Portfolio - MR Conditional | DZE | 2023-02-02 | 192 |
| K202524 | Standard Sterilizable Tray | KCT | 2021-01-28 | 149 |
| K201553 | Simply Iconic Implants | DZE | 2021-01-22 | 226 |
| K200858 | Mini Sterilizable Tray | KCT | 2020-08-06 | 127 |
| K200265 | Surgical Drills | DZI | 2020-06-30 | 148 |
| K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts | DZE | 2020-06-25 | 315 |
| K192218 | Custom Legacy and Custom InterActive Titanium Abutments | NHA | 2020-05-08 | 267 |
| K191458 | Legacy SMARTBase Abutments | NHA | 2019-10-10 | 132 |
7 earlier clearances. See the full list in Caduvo.
Recalls
33 product recalls in 30 recall events; 2 initiated in the last five years. Most recent: 2025-05-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Implant Innovations, Inc. (51 510(k)s)
- Implant Center of the Palm Beaches (20 510(k)s)
- Implant Innovations International, Inc. (18 510(k)s)
- Implant Technology, Inc. (13 510(k)s)
- Implant Direct, LLC (10 510(k)s)
- Implant Support Systems, Inc. (10 510(k)s)
- Implant Protesis Dental 2004, S.L. (6 510(k)s)
- Implant Sciences Corp. (6 510(k)s)
- Implant Integration Systems, Inc. (4 510(k)s)
- Implant Corp. of America (3 510(k)s)
- Implant Logistics, Inc. (3 510(k)s)
- Implant Resource, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Implant Direct Sybron Manufacturing, LLC?
FDA lists 17 510(k) clearances under the applicant name “Implant Direct Sybron Manufacturing, LLC” (first 2013, latest 2023), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Implant Direct Sybron Manufacturing, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Implant Direct Sybron Manufacturing, LLC is 209 days. Since 2017: 170 days, versus 189 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Implant Direct Sybron Manufacturing, LLC?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 6); NHA (Abutment, Implant, Dental, Endosseous, 6); KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 3).
Next steps
- See all 17 Implant Direct Sybron Manufacturing, LLC clearances with predicates and recalls
- Run predicate analysis for product code DZE, Implant Direct Sybron Manufacturing, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.