Sds Dental, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Sds Dental, Inc.” (first 1986, latest 1999), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 54 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | 4 | 4 |
| BWN | Table And Attachments, Operating-Room | 1 | 1 |
| EAZ | Light, Operating, Dental | 1 | 1 |
| ECB | Unit, Syringe, Air And/Or Water | 1 | 1 |
| EJP | Articulators | 1 | 1 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
| FSY | Light, Surgical, Ceiling Mounted | 1 | 1 |
| HME | Chair, Ophthalmic, Ac-Powered | 1 | 1 |
| KLC | Chair, Dental, With Operative Unit | 1 | 1 |
| KOJ | Airbrush | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (10)
- General and Plastic Surgery (2)
- Ophthalmic (1)
Most recent Sds Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990546 | DELSONIC 2000 | ELC | 1999-11-05 | 256 |
| K990545 | JETSONIC 2000 | KOJ | 1999-08-11 | 170 |
| K964619 | DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) | EIA | 1997-01-22 | 65 |
| K902865 | BAUMER SURGICAL TABLE | BWN | 1990-09-10 | 73 |
| K902864 | SURGICAL LIGHTING-CENTRA 450 | FSY | 1990-09-10 | 73 |
| K863011 | DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II | — | 1986-10-10 | 63 |
| K863021 | CM-II, CM-I WATER UNIT | EIA | 1986-10-01 | 54 |
| K863016 | DENTATUS L SET | KLC | 1986-10-01 | 54 |
| K863015 | ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT | — | 1986-10-01 | 54 |
| K863014 | ISOPRAT F-III SET/ISOLAX CHAIR | — | 1986-10-01 | 54 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sds Dental, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sds Dental, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Sds Dental, Inc.” (first 1986, latest 1999), across 11 product codes in 3 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 Sds Dental, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sds Dental, Inc. is 54 days.
Which FDA product codes appear under Sds Dental, Inc.?
The most frequent FDA product codes under this applicant name are EIA (Unit, Operative Dental, 4); BWN (Table And Attachments, Operating-Room, 1); EAZ (Light, Operating, Dental, 1).
Next steps
- See all 21 Sds Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIA, Sds Dental, 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, 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.