Manufacturer registered with FDA
Osseo Scientific, LLC
Toms River, NJ, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 7
- 510(k) clearances
- 12007–2007
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Devices listed with FDA
What Osseo Scientific, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | AIR POWERED DENTAL HANDPIECEContra Angles and Dental HeadsDental Handpieces and TurbinesDental Highspeed and TurbinesIntegrity | 2008 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Low Temp Dental Drill | 2012 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | Contra Angles and Dental Heads | 2012 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Osseo Scientific, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 25 Jan 2007 | K070155 | INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC | EFB Dental Air-Powered Handpiece |
Some of these clearances are listed with FDA today by another company: Ultradent Products, Inc. (1).
Also lists devices cleared under other names
Osseo Scientific, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Nakamura Magnifier Co., Ltd. (1), Promident, LLC (1), Microtech (1), Promident Mfg., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Mar 2008 | K073652 | ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE | Nakamura Magnifier Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 7 Feb 2008 | K080240 | CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE | Promident, LLC | EFB Dental Air-Powered Handpiece |
| 22 Oct 2002 | K022535 | MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100 | Microtech | EFB Dental Air-Powered Handpiece |
| 15 Nov 1978 | K781545 | AIR POWERED DENTAL HANDPIECE | Promident Mfg., Ltd. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OSSEO SCIENTIFIC, LLCFDA reg. 3005405362 | Dover Township, NJ, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9078740). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.