The following data is part of a premarket notification filed by Osseo Scientific, Llc with the FDA for Integrity Low Speed Dental Air Handpiece And Attachment, Models: Motor Int-e, Motor Int-d And Attachment Int-snc.
| Device ID | K070155 |
| 510k Number | K070155 |
| Device Name: | INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | OSSEO SCIENTIFIC, LLC 3138 VEEDER AVE. Toms River, NJ 08753 |
| Contact | Michael Feldman |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-01-17 |
| Decision Date | 2007-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205028082 | K070155 | 000 |
| 00850012724254 | K070155 | 000 |
| 00850012724247 | K070155 | 000 |
| 00850012724230 | K070155 | 000 |
| 00850012724223 | K070155 | 000 |
| 00850012724179 | K070155 | 000 |
| 00850012724162 | K070155 | 000 |
| 00850012724155 | K070155 | 000 |
| 00850012724148 | K070155 | 000 |
| 00850012724131 | K070155 | 000 |
| 00850012724216 | K070155 | 000 |
| 00850012724209 | K070155 | 000 |
| 00810113691008 | K070155 | 000 |
| 00850012724261 | K070155 | 000 |
| 00850012724278 | K070155 | 000 |
| 00850012724285 | K070155 | 000 |
| 00883205028075 | K070155 | 000 |
| 00883205028068 | K070155 | 000 |
| 00883205028051 | K070155 | 000 |
| 00883205028044 | K070155 | 000 |
| 00883205028037 | K070155 | 000 |
| 00883205028020 | K070155 | 000 |
| 00883205020062 | K070155 | 000 |
| 00883205020055 | K070155 | 000 |
| 00883205020048 | K070155 | 000 |
| 00883205004895 | K070155 | 000 |
| 00883205004864 | K070155 | 000 |
| 00850012724292 | K070155 | 000 |
| 00810113690339 | K070155 | 000 |