The following data is part of a premarket notification filed by Nakamura Magnifier Co., Ltd. with the FDA for Nd Low Speed Airmotor And Handpiece, Highspeed Airturbine Handpiece, E-type Straight Nosecone And Contra Angle.
| Device ID | K073652 |
| 510k Number | K073652 |
| Device Name: | ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDPIECE, E-TYPE STRAIGHT NOSECONE AND CONTRA ANGLE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NAKAMURA MAGNIFIER CO., LTD. 17972 SKY PARK CIRCLE SUITE J Irvine, CA 92614 |
| Contact | Charlie Ito |
| Correspondent | Charlie Ito NAKAMURA MAGNIFIER CO., LTD. 17972 SKY PARK CIRCLE SUITE J Irvine, CA 92614 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-26 |
| Decision Date | 2008-03-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810988030339 | K073652 | 000 |
| 00304040057971 | K073652 | 000 |
| 00304040057964 | K073652 | 000 |
| 00304040057957 | K073652 | 000 |
| 00304040057865 | K073652 | 000 |
| 00304040057841 | K073652 | 000 |
| 00304040057827 | K073652 | 000 |
| 00304040057810 | K073652 | 000 |
| 00304040057803 | K073652 | 000 |
| 00304040057780 | K073652 | 000 |
| 00304040057773 | K073652 | 000 |
| 00304040057766 | K073652 | 000 |
| 00304040057759 | K073652 | 000 |
| 00304040057742 | K073652 | 000 |
| 00889813044155 | K073652 | 000 |
| 00889813044087 | K073652 | 000 |
| 00304040057988 | K073652 | 000 |
| 00304040057995 | K073652 | 000 |
| 00304040058008 | K073652 | 000 |
| H83475400 | K073652 | 000 |
| H83475160 | K073652 | 000 |
| H834750150 | K073652 | 000 |
| H834750140 | K073652 | 000 |
| H83475120 | K073652 | 000 |
| H83475301 | K073652 | 000 |
| H83475281 | K073652 | 000 |
| H83475260 | K073652 | 000 |
| H83475240 | K073652 | 000 |
| H83475220 | K073652 | 000 |
| H83475200 | K073652 | 000 |
| 00304040095553 | K073652 | 000 |
| 00304040059654 | K073652 | 000 |
| 00304040058053 | K073652 | 000 |
| 00304040058046 | K073652 | 000 |
| D826501340 | K073652 | 000 |