The following data is part of a premarket notification filed by Nsk Nakanishi, Inc. with the FDA for E-type Speed Increaser Contra Angle, External Irrigation, Internal Irrigation.
| Device ID | K972569 |
| 510k Number | K972569 |
| Device Name: | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken, JP 322 |
| Contact | Hiroji Sekiguchi |
| Correspondent | Hiroji Sekiguchi NSK NAKANISHI, INC. 340 KAMIHINATA,KANUMA-SHI Tochigi-ken, JP 322 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-10 |
| Decision Date | 1997-10-08 |