Mis Implants Technologies , Ltd.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Mis Implants Technologies , Ltd.” (first 2001, latest 2019), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 142 days. Since 2017 the median was 147 days, against 193 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 Dentsply Sirona, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 378 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 155 |
| 2018 | 2 | 144 |
| 2019 | 1 | 165 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mis Implants Technologies , Ltd. took a median 147 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 193 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 8 | 8 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 | 1 |
| OLR | Oral Wound Dressing | 1 | 1 |
Review panels
- Dental (13)
Most recent Mis Implants Technologies , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182228 | MIS LOCKiT Abutments System, OT-Equators and Ball Attachments | NHA | 2019-01-28 | 165 |
| K180282 | MIS Internal Hex Dental Implant System | DZE | 2018-06-22 | 142 |
| K173326 | MIS CONNECT Conical Connection Abutment | NHA | 2018-03-16 | 147 |
| K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments | DZE | 2017-12-28 | 132 |
| K163349 | MIS V3 Conical Connection Dental Implant System | DZE | 2017-05-26 | 178 |
| K112162 | CONICAL CONNECTION IMPLANTS | DZE | 2012-08-08 | 378 |
| K110750 | PERIOPATCH | OLR | 2011-04-28 | 42 |
| K101014 | BOND BONE | LYC | 2010-10-21 | 192 |
| K092555 | UNO NARROW IMPLANT | DZE | 2010-01-05 | 138 |
| K080162 | UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT | DZE | 2008-04-22 | 90 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mis Implants Technologies , Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mis Implants Technologies , Ltd.?
FDA lists 13 510(k) clearances under the applicant name “Mis Implants Technologies , Ltd.” (first 2001, latest 2019), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Mis Implants Technologies , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mis Implants Technologies , Ltd. is 142 days. Since 2017: 147 days, versus 193 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mis Implants Technologies , Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 8); NHA (Abutment, Implant, Dental, Endosseous, 2); LYC (Bone Grafting Material, Synthetic, 1).
Next steps
- See all 13 Mis Implants Technologies , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Mis Implants Technologies , Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.