The following data is part of a premarket notification filed by Nakamura Dental Handpiece Mfg. Co., Ltd. with the FDA for Nd Lowspeed Airmotor,nd Highspeed Airturbine Handpiece.
| Device ID | K113222 |
| 510k Number | K113222 |
| Device Name: | ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. 59-2 MINAMI-CHO Itabashi-ku, Tokyo, JP 173-0027 |
| Contact | Shinichi Nakamura |
| Correspondent | Shinichi Nakamura NAKAMURA DENTAL HANDPIECE MFG. CO., LTD. 59-2 MINAMI-CHO Itabashi-ku, Tokyo, JP 173-0027 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-01 |
| Decision Date | 2012-02-23 |