Planmeca U.S.A. Inc
Hoffman Est, IL, US
Planmeca U.S.A. Inc appears in FDA device records in Hoffman Est, IL. FDA records list 13 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Planmeca U.S.A. Inc between 1984 and 2011. The busiest year on record is 1984, with 3. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 3 |
| 1986 | 1 |
| 1991 | 3 |
| 1992 | 2 |
| 1993 | 1 |
| 1994 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K111361 | PLANMED NUANCE EXCEL | MUE | Substantially Equivalent | |
| K081699 | PLANMECA SOVEREIGN | EIA | Substantially Equivalent | |
| K923534 | PM2002 PROLINE | KLC | Substantially Equivalent | |
| K923533 | ADMARK | JAC | Substantially Equivalent | |
| K923462 | DELIGHT | EAZ | Substantially Equivalent | |
| K923461 | PM2002 PROLINE, PM2002 PROLINE EC | KLC | Substantially Equivalent | |
| K904953 | PLANMED SOPHIE | IZH | Substantially Equivalent | |
| K904948 | PM2002 CC AND PM2002 EC | EIA | Substantially Equivalent | |
| K904947 | PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE | BZG | Substantially Equivalent | |
| K864474 | DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC | EHD | Substantially Equivalent | |
| K842359 | AUTOMATIC PATIENT CHAIR PM2000 & A | Substantially Equivalent | ||
| K842357 | PM 2000 DENTAL UNIT | EIA | Substantially Equivalent | |
| K842358 | ISOLIGHT | EBA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3027544687 | 3027544687 | Planmeca U.S.A. Inc | 11727 Fruehauf Dr., Charlotte, NC 28273 US | 2026 | No device listings on this registration |
| 2183536 | 1421092 | Planmeca U.S.A. Inc. | 2600 Forbs Ave., Hoffman Est, IL 60192 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KLCChair, Dental, With Operative Unit
- MUEFull Field Digital, System, X-Ray, Mammographic
- EAZLight, Operating, Dental
- EBALight, Surgical Headlight
- BZGSpirometer, Diagnostic
- JACSystem, X-Ray, Film Marking, Radiographic
- IZHSystem, X-Ray, Mammographic
- EIAUnit, Operative Dental
- EHDUnit, X-Ray, Extraoral With Timer
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Planmeca U.S.A. Inc edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain