Dentaurum Inc.
Langhorne, PA, US
Dentaurum Inc. appears in FDA device records in Langhorne, PA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. 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 10 510(k) clearances for Dentaurum Inc. between 2001 and 2006. The busiest year on record is 2003, with 5. The most recent is 2006, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2003 | 5 |
| 2005 | 1 |
| 2006 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K062733 | TOMAS PIN SD 6, 8, AND 10 MM | OAT | Substantially Equivalent | |
| K062732 | TOMAS PIN 6 MM | OAT | Substantially Equivalent | |
| K042965 | TOMAS PIN | OAT | Substantially Equivalent | |
| K030644 | CONTEC DUO, CONTEC LC, CONTEC LCR | DYH | Substantially Equivalent | |
| K032195 | DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT | DYH | Substantially Equivalent | |
| K030980 | DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVE | DYH | Substantially Equivalent | |
| K030977 | DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE | DYH | Substantially Equivalent | |
| K030641 | CONTEC LIGHT | EBZ | Substantially Equivalent | |
| K011428 | TRICERAM | EIH | Substantially Equivalent | |
| K011425 | CARMEN | EIH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2521672 | 2521672 | Dentaurum Inc. | 2050 Cabot Boulevard West, Langhorne, PA 19047 US | 2026 | No device listings on this registration |
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