The following data is part of a premarket notification filed by Spintech, Inc. with the FDA for Shortstop Disposable Prophy Angle.
Device ID | K955654 |
510k Number | K955654 |
Device Name: | SHORTSTOP DISPOSABLE PROPHY ANGLE |
Classification | Handpiece, Air-powered, Dental |
Applicant | SPINTECH, INC. 218 DEW DROP RD. York, PA 17402 |
Contact | Ronald P Spinello |
Correspondent | Ronald P Spinello SPINTECH, INC. 218 DEW DROP RD. York, PA 17402 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-12 |
Decision Date | 1996-02-08 |