The following data is part of a premarket notification filed by Dw Industries, Inc. with the FDA for Sani-shield.
| Device ID | K970104 |
| 510k Number | K970104 |
| Device Name: | SANI-SHIELD |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DW INDUSTRIES, INC. 601 13TH ST. N.W. SUITE 500 NORTH Washington, DC 20005 |
| Contact | Terry G Mahn |
| Correspondent | Terry G Mahn DW INDUSTRIES, INC. 601 13TH ST. N.W. SUITE 500 NORTH 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 | 1997-01-13 |
| Decision Date | 1997-05-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SANI-SHIELD 86665389 5074324 Live/Registered |
Simoniz USA, Inc. 2015-06-17 |
![]() SANI-SHIELD 78750922 3157997 Live/Registered |
PROACTIVE SOLUTIONS LLC 2005-11-09 |
![]() SANI-SHIELD 75510476 2358481 Live/Registered |
Unelko Corporation 1998-06-24 |
![]() SANI-SHIELD 74734280 2002945 Live/Registered |
DENTSPLY SIRONA INC. 1995-09-25 |
![]() SANI-SHIELD 73835723 1660705 Dead/Cancelled |
SANDERSON PLUMBING PRODUCTS, INC. 1989-10-13 |
![]() SANI-SHIELD 72338521 0915343 Dead/Expired |
ARMOUR-DIAL, INC. 1969-09-22 |