Kavo America: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Kavo America” (first 1991, latest 2008), plus 1 De Novo decision, across 14 product codes in 4 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| EFB | Handpiece, Air-Powered, Dental | 3 | 3 |
| EIH | Powder, Porcelain | 3 | 3 |
| NBL | Light-Induced Fluorescence Caries Detector | 3 | 2 |
| KOJ | Airbrush | 2 | 2 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| EJH | Alloy, Metal, Base | 1 | 1 |
Plus 4 more product codes.
Review panels
- Dental (17)
- General and Plastic Surgery (4)
- Radiology (2)
- General Hospital (1)
Most recent Kavo America 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073074 | KEY LASER III 1243 US WITH DETECT | GEX | 2008-07-10 | 253 |
| K072262 | GENTLERAY 980 DIODE LASER SYSTEM | GEX | 2007-10-26 | 72 |
| K063624 | KAVO EVEREST C-TEMP | EBG | 2007-02-08 | 64 |
| K051909 | DIAGNODENT | NBL | 2005-10-21 | 99 |
| K030146 | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ | NVK | 2005-08-03 | 931 |
| K042394 | DIAGNODENT PERIO TIP (ACCESSORY) | NBL | 2005-08-02 | 334 |
| K050744 | KAVO ERGOCOM/ERGOCAM | LLZ | 2005-04-21 | 30 |
| K050019 | IN EXAM INTRAORAL DENTAL X-RAY SYSTEM | EHD | 2005-01-31 | 26 |
| K042872 | RONDOFLEX PLUS 360 | KOJ | 2004-11-23 | 36 |
| K033221 | KAVO EVEREST ZH-BLANK | EIH | 2003-10-28 | 25 |
13 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN990002 | De Novo | Light-Induced Fluorescence Caries Detector | 2000-02-22 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2006-11-22.
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.
- Kavo Dental GmbH (2 510(k)s)
- Kavo Dental Technologies, LLC (1 510(k)s)
- Kavo DO Brasil Industria E Comercio Ltda (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kavo America?
FDA lists 23 510(k) clearances under the applicant name “Kavo America” (first 1991, latest 2008), plus 1 De Novo decision, across 14 product codes in 4 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 Kavo America?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kavo America is 82 days.
Which FDA product codes appear under Kavo America?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 4); EFB (Handpiece, Air-Powered, Dental, 3); EIH (Powder, Porcelain, 3).
Next steps
- See all 23 Kavo America clearances with predicates and recalls
- Run predicate analysis for product code GEX, Kavo America'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.