Data / Medical devices / United States / Osseo Scientific, LLC
Osseo Scientific, LLC: FDA-registered device maker in Dover Township, NJ, United States, 5 510(k) clearances
Osseo Scientific, LLC is registered with the FDA (registration 3005405362) in Dover Township, NJ, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 20, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005405362
- Address
- 2008 Route 37 East Unit No. 16, Dover Township, NJ, United States, 08753
- Owner or operator
- OSSEO SCIENTIFIC, LLC (9078740)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- April 24, 2008
- Registered through
- 2026
- Brand names listed
- AIR POWERED DENTAL HANDPIECE, Contra Angles and Dental Heads, Dental Handpieces and Turbines, Dental Highspeed and Turbines, Integrity, Low Temp Dental Drill
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 20, 2008 | K073652 | ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE | EFB | Substantially Equivalent | Nakamura Magnifier Co., Ltd. | accessdata.fda.gov |
| February 7, 2008 | K080240 | CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE | EFB | Substantially Equivalent | Promident, LLC | accessdata.fda.gov |
| January 25, 2007 | K070155 | INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC | EFB | Substantially Equivalent | Osseo Scientific, LLC | accessdata.fda.gov |
| October 22, 2002 | K022535 | MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100 | EFB | Substantially Equivalent | Microtech | accessdata.fda.gov |
| November 15, 1978 | K781545 | AIR POWERED DENTAL HANDPIECE | EFB | Substantially Equivalent | Promident Mfg., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Dental, Intraoral
- All makers of Handpiece, Air-Powered, Dental
- All makers of Handpiece, Contra- And Right-Angle Attachment, Dental
Updated March 20, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.