The following data is part of a premarket notification filed by Nakanishi, Inc. with the FDA for Care3 Plus.
| Device ID | K081811 |
| 510k Number | K081811 |
| Device Name: | CARE3 PLUS |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NAKANISHI, INC. 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Keith Barritt |
| Correspondent | Keith Barritt NAKANISHI, INC. 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-26 |
| Decision Date | 2009-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560264539013 | K081811 | 000 |
| 04560264536609 | K081811 | 000 |
| 04560264574090 | K081811 | 000 |
| 04560264574106 | K081811 | 000 |
| 04560264574113 | K081811 | 000 |
| 04560264573345 | K081811 | 000 |
| 04560264573352 | K081811 | 000 |
| 04560264573369 | K081811 | 000 |
| 04560264573376 | K081811 | 000 |
| 04560264573383 | K081811 | 000 |
| 04560264573390 | K081811 | 000 |
| 04560264573406 | K081811 | 000 |
| 04560264573413 | K081811 | 000 |
| 04560264573420 | K081811 | 000 |
| 04560264573437 | K081811 | 000 |
| 04560264572690 | K081811 | 000 |
| 04560264538986 | K081811 | 000 |
| 04560224988097 | K081811 | 000 |