Minimatic Implant Technology: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Minimatic Implant Technology” (first 1990, latest 1992), across 1 product code in 1 review panel. Median 510(k) review time under this name: 146 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 34 | 34 |
Review panels
- Dental (34)
Most recent Minimatic Implant Technology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K911776 | DPI-1106 IMPLANT, MODIFICATION | DZE | 1992-01-15 | 289 |
| K903515 | HH-1119 HEALING HEAD | DZE | 1991-07-04 | 335 |
| K911112 | DEVICE PART NUMBERS: - 1400 SERIES | DZE | 1991-06-10 | 117 |
| K905039 | IMPLANT, THREADED EXTERNAL HEX, TAPERED SHOULDER | DZE | 1991-04-29 | 174 |
| K904707 | BC 1208 IMPLANT, THREADED EXTERNAL HEX | DZE | 1991-04-29 | 195 |
| K903046 | IDT-1104 IMPLANT (SCREW-IN-THREADED) | DZE | 1991-04-19 | 282 |
| K903043 | ICT-1108 IMPLANT- THREADED (CEMENT TYPE ABUTMENT) | DZE | 1991-04-19 | 282 |
| K904705 | BC 1206 IMPLANT - INSERT TYPE | DZE | 1991-04-12 | 178 |
| K904712 | BC 1221 BALL OVERDENTURE ATTACHMENT | DZE | 1991-03-29 | 164 |
| K904710 | BC 1219 HEALING HEAD | DZE | 1991-03-29 | 164 |
24 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Minimatic Implant Technology.
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.
- Minimatic, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Minimatic Implant Technology?
FDA lists 34 510(k) clearances under the applicant name “Minimatic Implant Technology” (first 1990, latest 1992), across 1 product code 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 Minimatic Implant Technology?
The median time from FDA receipt to decision across 510(k)s cleared under the name Minimatic Implant Technology is 146 days.
Which FDA product codes appear under Minimatic Implant Technology?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 34).
Next steps
- See all 34 Minimatic Implant Technology clearances with predicates and recalls
- Run predicate analysis for product code DZE, Minimatic Implant Technology'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.