Oral-B Laboratories
Iowa City, IA, US
ORAL-B LABORATORIES appears in FDA device records in Iowa City, IA. FDA records list 8 510(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 8 510(k) clearances for Oral-B Laboratories between 1988 and 1995. The busiest year on record is 1993, with 3. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1991 | 1 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K943157 | ORAL-B ULTRAFLOSS WITH FLLUORIDE | JES | Substantially Equivalent | |
| K942633 | ORAL-B INTERDENTAL WOODSTICKS WITH FLUORIDE | JET | Substantially Equivalent | |
| K943182 | ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR | EFS | Substantially Equivalent | |
| K932990 | ORAL-B DISPOSABLE PROPHY ANGLE W/PROPHY CUP | EFB | Substantially Equivalent | |
| K925409 | ORAL-B DENTAL FLOSS WITH FLUORIDE | JES | Substantially Equivalent | |
| K925408 | ORAL-B DENTAL TAPE WITH FLUORIDE | JES | Substantially Equivalent | |
| K913603 | FIBRETWINS | KNT | Substantially Equivalent | |
| K883024 | ORAL-B FLOSSERS | JES | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1910469 | 1910469 | ORAL-B LABORATORIES | 1832 LOWER MUSCATINE RD., IOWA CITY, IA 52240 US | 2026 | |
| 3013646822 | 3013646822 | ORAL-B LABORATORIES | 1375 Highway 1 W, Iowa City, IA 52246 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain