Implant Support Systems, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Implant Support Systems, Inc.” (first 1989, latest 1994), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 279 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 | 7 | 7 |
| EGG | Attachment, Precision, All | 1 | 1 |
| EKJ | Burnisher, Operative | 1 | 1 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Dental (10)
Most recent Implant Support Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933532 | SELF TAPPING DENTAL IMPLANT SYSTEM | DZE | 1994-09-21 | 427 |
| K924589 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | DZE | 1994-06-22 | 650 |
| K925312 | HAND INSTRUMENT CALCULUS REMOVAL | DZE | 1994-05-23 | 579 |
| K925313 | TITANIUM COC ABUTMENT HEADS FOR IMZ | DZE | 1993-07-30 | 282 |
| K925349 | ONE SYSTEM TAPERED TITANIUM ABUTMENTS | NHA | 1993-07-27 | 278 |
| K924190 | ISS O-RING ATTACHMENT | DZE | 1993-05-27 | 280 |
| K921764 | DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS | DZE | 1992-11-03 | 203 |
| K904605 | TITANIUM COC ABUTMENT HEADS FOR IMZ | DZE | 1991-01-29 | 111 |
| K895986 | PRECISION DENTAL ATTACHMENTS | EGG | 1989-10-18 | 90 |
| K892239 | DENTAL HAND INSTRUMENTS | EKJ | 1989-05-18 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Implant Support Systems, Inc..
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 (32 510(k)s)
- Implant Innovations International, Inc. (18 510(k)s)
- Implant Direct Sybron Manufacturing, LLC (17 510(k)s)
- Implant Technology, Inc. (13 510(k)s)
- Implant Direct, LLC (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 Support Systems, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Implant Support Systems, Inc.” (first 1989, latest 1994), across 4 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 Implant Support Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Implant Support Systems, Inc. is 279 days.
Which FDA product codes appear under Implant Support Systems, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 7); EGG (Attachment, Precision, All, 1); EKJ (Burnisher, Operative, 1).
Next steps
- See all 10 Implant Support Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Implant Support Systems, Inc.'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.